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This study evaluates the cost-effectiveness of the geko device a neuromuscular electro-stimulator technology with standard of care (SoC) versus SoC alone for venous leg ulcer (VLU) treatment, from the UK National Health Service (NHS) perspective over 12 months. Research was conducted across NHS UK facilities, primarily within community services and outpatient leg ulcer clinics, encompassing a total of 51 patients. A partitioned survival model, based on a two-arm randomised controlled trial, assessed wound healing rates using Kaplan-Meier curves and parametric extrapolations over a 12-month time horizon. Costs were derived from UK reference costs the British National Formulary, and the Personal Social Services Research Unit (2021/22). The primary outcome measured was the incremental cost per quality-adjusted life-year gained. The geko device provides additional benefits by stimulating the lateral popliteal nerve, augmenting venous, arterial, and microvascular flow. The addition of the geko device to SoC significantly enhanced outcomes, increasing healing probability by 68% compared to SoC. This integration would result in a cost saving of £774.14 per patient when compared to the SoC alone across the NHS. Economic analyses indicate that integrating the geko device into SoC protocols would reduce the overall NHS expenditure on VLU wound management by as much as 15%. The approach also positively impacted health-related quality of life. The geko™ device when used adjunctively with SoC would be a cost-effective method for managing chronic VLUs within the NHS, improving healing rates and offering economic benefits., (© 2024 The Author(s). International Wound Journal published by Medicalhelplines.com Inc and John Wiley & Sons Ltd.)

Objective: Multicomponent bandages (MCBs) are recommended by the French Authority for Health (Haute Autorité de Santé) as first-line treatment for venous leg ulcers (VLUs). A first analysis of the data collected from the French administrative healthcare database (Système National des Données de Santé (SNDS)) on 25,255 patients with a VLU supported superiority of MCBs versus short stretch bandages when considering the healing outcomes and costs associated with closure of these wounds. The aim of this study was to assess how beneficial the primary dressing (technology lipido-colloid nano-oligosaccharide factor (TLC NOSF) or control dressing group (CDG)) could be, when used in combination with MCBs in the treatment of VLUs., Method: Data from the SNDS were collected for patients meeting the following inclusion criteria: treatment for a VLU with MCBs and with the same dressing type (TLC-NOSF or CDG) during the whole treatment period. Healing outcomes were documented on the global cohorts and propensity score-matched cohorts. The mean healthcare cost and the ecological impact were calculated for those patients healed within the study period., Results: In total, 12,507 patients met the criteria for treatment with both MCBs and TLC-NOSF dressings (n=1134) versus MCBs and CDG (n=11,373); with 1134 and 2268 patients per group following propensity score matching. Healing outcomes were favourable for the TLC-NOSF group in the global cohort and were enhanced in the propensity score-matched cohorts. At every point of the analysis, the adjusted healing rates were significantly higher in the TLC-NOSF group than in the CDG group (p<0.001). In the propensity score-matched cohorts (n=3402), the healing rate at three months was 52% in the TLC-NOSF group versus 37% in the CDG group (p<0.001). The median healing time was 87 days versus 125.5 days in the TLC-NOSF and CDG groups, respectively (p<0.0001). TLC-NOSF dressings significantly reduced the average treatment cost per healed ulcer (€2099) by 23.7% compared with dressings without TLC-NOSF (€2751) (p<0.001), as well as the resources used., Conclusion: This SNDS analysis confirms, in the largest real-life study performed in VLU management, the superiority of the TLC-NOSF dressings versus those not impregnated with the NOSF compound. Better clinical outcomes associated with cost savings and a positive ecological impact support the combination of MCBs and TLC-NOSF dressings and should be considered as an optimal standard of care for the global management of VLUs. These outcomes reinforce the current positions of the international guidelines on the use of NOSF impregnated dressings (UrgoStart range; Laboratoires Urgo, France) in this pathology.

Introduction: Vascular ulcers constitute a serious global public health problem, responsible for causing a significant social and economic impact due to their recurrent, disabling nature and the need for prolonged therapies to cure them., Objective: To evaluate the use and efficacy of the rhEGF in the epithelialization of patients with a diagnosis of CEAP stage 6 venous insufficiency, in the two regimes of the health system in Colombia, the contributive (equivalent to a health system where citizens with payment capacity contribute a percentage of their salary) and the subsidized (equivalent to a health system where the state covers the vulnerable population and low socioeconomic level) versus the other treatments used., Methodology: Observational, descriptive, retrospective, multicenter study, in which 105 medical records with 139 ulcers were reviewed, in 2 centers, one belonging to the subsidized system and the other to the contributive system in Colombia., Results: The association with the epithelialization variable of the different treatment groups for ulcers according to the application of the mixed effect model test, for both regimes was for the Biologicals (EC 34.401/p = 0.000), Bioactive Agents (Hydrogels) (EC 24.735/p = 0.005) groups; for the rest of the treatment groups, the results were neither associated nor statistically significant., Conclusion: Intra- and perilesional therapy with rhEGF expands the therapeutic spectrum in patients with venous ulcers, regardless of the type of health system in which it will be applied, shortening the healing time and reaching a possible therapeutic goal, which according to this study there is an association with epithelialization regardless of the regime applied., Competing Interests: The authors report no conflicts of interest in this work., (© 2024 Cacua Sanchez et al.)

Objective: To determine the impact of infection (INF) on medical resource utilization (MRU) and cost of care in patients with venous leg ulcers (VLU)., Methods: We performed a retrospective case-control study of 78 patients followed for a minimum of 12 months with C 6 VLUs treated by vascular surgeons, at our wound center. To eliminate minor episodes of INF or incorrectly diagnosed episodes, only patients who had an inpatient admission specifically for INF comprised the INF group, whereas all other admissions were excluded for this group. MRU was defined as the number of clinic visits, Visiting Nurse Association (VNA) visits, and inpatient admissions. The actual cost for treatment was determined using financial data provided by both the hospital and physician organization billing units. The total cost over the 1-year follow-up period comprised individual cost centers: inpatient and outpatient facility fees, physician fees, and visiting nurse services. Mean MRU and cost data were compared using the two-sample t-test between INF and NON-INF., Results: Of the 78 patients with C 6 VLU, 9 (11.5%) had at least one inpatient admission for INF related to their VLU in the 1-year treatment period, with an additional five recurrent admissions for a total of 14 admissions, whereas 69 NON-INF had three NON-INF-related admissions. There was no difference between INF and NON-INF for usual risk factors, but INF had a greater proportion of congestive heart failure (44%; 13%, P < .02). Regarding MRU, both the number of outpatient wound center visits (INF 16.89 ± 6.41; NON-INF 9.46 ± 7.7, P = .008) and VNA blocks (INF 3.89 ± 2.93; NON-INF 1.94 ± 2.24, P < .02) were greater for INF. Total costs for INF ($27,408 ± $10,859) were threefold higher than those for NON-INF ($11,088 ± $9343, P < .0001) and subsequent VNA costs were doubled for INF ($9956 ± $4657) vs NON-INF ($4657 ± $5486, P = .01)., Conclusions: INFs in patients with VLU led to an overall increase in MRU and cost of care, with the INF cohort requiring more inpatient admissions, outpatient visits, and VNA services than NON-INF. Given the major impact INF has on cost and MRU, better treatment modalities that prevent INF as well as identifying risk factors for INF in patients with VLU are needed., (Copyright © 2021 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Importance: One-year outcomes from the Early Venous Reflux Ablation (EVRA) randomized trial showed accelerated venous leg ulcer healing and greater ulcer-free time for participants who are treated with early endovenous ablation of lower extremity superficial reflux., Objective: To evaluate the clinical and cost-effectiveness of early endovenous ablation of superficial venous reflux in patients with venous leg ulceration., Design, Setting, and Participants: Between October 24, 2013, and September 27, 2016, the EVRA randomized clinical trial enrolled 450 participants (450 legs) with venous leg ulceration of less than 6 months' duration and superficial venous reflux. Initially, 6555 patients were assessed for eligibility, and 6105 were excluded for reasons including ulcer duration greater than 6 months, healed ulcer by the time of randomization, deep venous occlusive disease, and insufficient superficial venous reflux to warrant ablation therapy, among others. A total of 426 of 450 participants (94.7%) from the vascular surgery departments of 20 hospitals in the United Kingdom were included in the analysis for ulcer recurrence. Surgeons, participants, and follow-up assessors were not blinded to the treatment group. Data were analyzed from August 11 to November 4, 2019., Interventions: Patients were randomly assigned to receive compression therapy with early endovenous ablation within 2 weeks of randomization (early intervention, n = 224) or compression with deferred endovenous treatment of superficial venous reflux (deferred intervention, n = 226). Endovenous modality and strategy were left to the preference of the treating clinical team., Main Outcomes and Measures: The primary outcome for the extended phase was time to first ulcer recurrence. Secondary outcomes included ulcer recurrence rate and cost-effectiveness., Results: The early-intervention group consisted of 224 participants (mean [SD] age, 67.0 [15.5] years; 127 men [56.7%]; 206 White participants [92%]). The deferred-intervention group consisted of 226 participants (mean [SD] age, 68.9 [14.0] years; 120 men [53.1%]; 208 White participants [92%]). Of the 426 participants whose leg ulcer had healed, 121 (28.4%) experienced at least 1 recurrence during follow-up. There was no clear difference in time to first ulcer recurrence between the 2 groups (hazard ratio, 0.82; 95% CI, 0.57-1.17; P = .28). Ulcers recurred at a lower rate of 0.11 per person-year in the early-intervention group compared with 0.16 per person-year in the deferred-intervention group (incidence rate ratio, 0.658; 95% CI, 0.480-0.898; P = .003). Time to ulcer healing was shorter in the early-intervention group for primary ulcers (hazard ratio, 1.36; 95% CI, 1.12-1.64; P = .002). At 3 years, early intervention was 91.6% likely to be cost-effective at a willingness to pay of £20 000 ($26 283) per quality-adjusted life year and 90.8% likely at a threshold of £35 000 ($45 995) per quality-adjusted life year., Conclusions and Relevance: Early endovenous ablation of superficial venous reflux was highly likely to be cost-effective over a 3-year horizon compared with deferred intervention. Early intervention accelerated the healing of venous leg ulcers and reduced the overall incidence of ulcer recurrence., Trial Registration: ClinicalTrials.gov identifier: ISRCTN02335796.

Background: Limb compression is a key component of protocols used to heal venous leg ulcers (VLUs). A novel ambulatory pneumatic compression device was tested in comparison with multilayered bandage (MLB) compression systems for the treatment of VLUs in a prospective randomized clinical trial., Methods: Patients with VLUs measuring 1.5 to 50 cm 2 with duration of 1 to 24 months were randomized to treatment with a pneumatic compression device, the ACTitouch adaptive compression therapy (ACT) system (Tactile Medical, Minneapolis, Minn), or MLB. The ACT group patients were seen in the clinic at weeks 1, 2, 4, 6, 9, 12, and 16 or until wounds healed; the MLB group was seen weekly for bandage and dressing changes for 16 weeks or until wounds healed. All other aspects of VLU care were standardized between the two groups. The primary study objective was to compare the VLU percentage area reduction at 16 weeks in the ACT group compared with the MLB group., Results: There were 56 patients randomized to treatment with ACT (n = 26) or MLB (n = 30). In the ACT group, five patients exited because of skin or wound problems related to the ACT device and five withdrew because of the inconvenience of using the device. Therefore, the trial was halted before full randomization so improvements to the ACT device could be made. Data collected on 42 patients who were able to tolerate treatment for the 16-week study period (per protocol group) showed that both groups experienced similar rates of wound healing. In the per protocol population, the percentage area size reduction was greater for the ACT group compared with the MLB group (83.8% vs 70.5%, respectively), whereas no significant differences were noted in the percentage of wounds that healed by 16 weeks (60.0% vs 63.0%, respectively)., Conclusions: In this truncated clinical trial, a novel dual-mode ambulatory compression device, when tolerated, achieved wound healing results similar to those with MLB for chronic VLUs. The device requires modifications to improve the patient's comfort and ease of use. However, this mode of therapy appears to have promise for improving the cost-effectiveness of treatment for chronic VLUs., (Copyright © 2020 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Background: Venous leg ulcers (VLUs) present a significant economic burden on the US healthcare system and payers (US$14.9 billion). Aim: To evaluate the quality of life (QoL) of patients with VLUs; to analyze the limitations of standard of care (SOC) for VLUs; and to explain how using bilayered living cellular construct (BLCC) with SOC for treatment of VLUs can help heal more VLUs faster (than using SOC alone) as well as help improve QoL and help reduce the burden on the US healthcare system and payers. Materials & methods: This is a review study. The search was conducted in February 2020 by way of electronic databases to find relevant articles that provided information related to QoL of patients with VLUs, limitations of SOC for VLUs and economic analyses of using BLCC for treatment of VLUs. Results: VLUs impact patients' physical, functional and psychological status and reduce QoL. A total 75% of VLU patients who used SOC alone failed to achieve healing in a timely fashion, which led to increased healthcare costs and healthcare resource utilization. Although the upfront cost is high, the greater effectiveness of BLCC offsets the added cost of the product during the time period of the studies. Therefore, BLCC helps to improve the QoL of VLU patients. As an example, for every 100 VLU patients in a healthcare plan, the use of BLCC can create cost savings of US$1,349,829.51. Conclusion: Payers' coverage of BLCC results in reduction of the overall medical cost for treating VLU patients.

The aim of this study was to estimate costs associated with the management of patients with venous leg ulcers (VLUs) from the perspective of the UK National Health Service (NHS). The analysis was undertaken through the Secure Anonymised Information Linkage Databank which brings together and anonymously links a wide range of person-based data from around 75% of general practitioner (GP) practices within Wales (population coverage ~2.5 million). The data covered an 11-year period from 2007 to 2017. All patients linked to the relevant codes were tracked through primary care settings, recording the number of GP practice visits (number of days with an event recorded), and wound treatment utilisation (eg, dressings, bandages, etc.) Resources were valued in monetary terms (£ sterling) and the costs were determined from national published sources of unit costs. This is the first attempt to estimate the costs of managing of VLUs using routine data sources. The direct costs to the Welsh NHS are considerable and represent 1.2% of the annual budget. Nurse visits are the main cost driver with annual estimates of £67.8 million. At a UK level, these costs amount to £1.98 billion. Dressings and compression bandages are also major cost drivers with annual Welsh estimates of £828 790. The direct cost of managing patients with VLUs is £7706 per patient per annum, which translates to an annual cost of over £2 billion, when extrapolated to the UK population. The primary cost driver is the number of district nurse visits. Initiatives to reduce healing times through improving accuracy of initial diagnosis, and improved evidence-based treatment pathways would result in major financial savings., (© 2020 The Authors. International Wound Journal published by Medicalhelplines.com Inc and John Wiley & Sons Ltd.)

Aim: To perform cost-effectiveness analysis (CEA) and budget impact analysis (BIA) comparing stenting to standard medical treatment (SMT) for the management of deep venous outflow obstruction and leg ulcers from the Italian Healthcare Service perspective. Materials & methods: A Markov model was developed to project costs and quality-adjusted life-years (QALYs) over 3 years, based on data from literature combined with real-world data. Moreover, a BIA was performed comparing the current scenario (100% SMT) with increasing utilization rates of stenting over SMT from 0.5 to 5%, in the next 5 years. Results: Stenting is a cost-effective (incremental cost-utility ratio €12,388/QALY) or dominant option versus SMT, according to in-patient or day-hospital settings, respectively. Increasing use of stenting over SMT, in the next 5 years, is expected to yield additional costs of 39.5 million Euros (in-patient) or savings of 5.1 million Euros (day-hospital). Conclusion: Stenting is a cost-effective option compared with SMT for patients with deep vein occlusion and ulceration in Italy.

Lower extremity ulcers such as venous leg ulcers (VLUs) and diabetic foot ulcers (DFUs) have a major clinical and economic impact on patients and providers., Purpose: The purpose of this economic evaluation was to determine the cost-effectiveness of single-use negative pressure wound therapy (sNPWT) compared with traditional NPWT (tNPWT) for the treatment of VLUs and DFUs in the United States., Methods: A Markov decision-analytic model was used to compare the incremental cost and ulcer weeks avoided for a time horizon of 12 and 26 weeks using lower extremity ulcer closure rates from a published randomized controlled trial (N = 161) that compared sNPWT with tNPWT. Treatment costs were extracted from a retrospective cost-minimization study of sNPWT and tNPWT from the payer perspective using US national 2016 Medicare claims data inflated to 2018 costs and multiplied by 7 to estimate the weekly costs of treatment for sNPWT and tNPWT. Two (2) arms of the model, tNPWT and sNPWT, were calculated separately for a combination of both VLU and DFU ulcer types. In this model, a hypothetical cohort of patients began in the open ulcer health state, and at the end of each weekly cycle a proportion of the cohort moved into the closed ulcer health state according to a constant transition probability. The costs over the defined timescale were summed to give a total cost of treatment for each arm of the model, and then the difference between the arms was calculated. Effectiveness was calculated by noting the incidence of healing at 12 and 26 weeks and the total number of open ulcer weeks; the incremental effectiveness was calculated as sNPWT effectiveness minus tNPWT effectiveness. Data were extracted to Excel spreadsheets and subjected to one-way sensitivity, scenario (where patients with unhealed ulcers were changed to standard care at 4 or 12 weeks), probabilistic, and threshold analyses., Results: sNPWT was found to provide an expected cost saving of $7756 per patient and an expected reduction of 1.67 open ulcer weeks per patient over 12 weeks and a cost reduction of $15 749 and 5.31 open ulcer weeks over 26 weeks. Probabilistic analysis at 26 weeks showed 99.8% of the simulations resulted in sNPWT dominating tNPWT. Scenario analyses showed that sNPWT remained dominant over tNPWT (cost reductions over 26 weeks of $2536 and $7976 per patient, respectively)., Conclusion: Using sNPWT for VLUs and DFUs is likely to be more cost-effective than tNPWT from the US payer perspective and may provide an opportunity for policymakers to reduce the economic burden of lower extremity ulcers.

Objective: This study evaluates the clinical and cost effectiveness of a 2-layer compression system (2LBA; 3M Coban Two-Layer Compression System; 3M, St Paul, MN) compared with other 2-layer (2LB) and 4-layer (4LB) compression systems in patients with noninfected venous leg ulcers (VLUs)., Methods: The MEDLINE, EMBASE, CINAHL, Cochrane Library, National Health Service (NHS) Economic Evaluation, and EconLit databases were searched from inception up to January 2017. The MEDLINE search was updated on March 31, 2017. Study selection, quality assessment, and data synthesis were undertaken in accordance with recommended standards. Findings were presented narratively., Results: In total, 5 studies (N = 1509 patients) of mixed methodological quality were included. At 6 months, 2LBA achieved better ulcer healing in comparison with 2LBB (odds ratio [OR], 1.57; 95% confidence interval [CI], 1.10-2.24; P = .03) and 4LBA (OR, 1.93, 95% CI, 1.26-2.97; P = .05) in patients with newly diagnosed ulcers only. For a combined population with newly diagnosed and existing VLUs, healing outcomes were OR, 2.87; 95% CI, 1.06-7.77; P = .04, and OR, 16.51; 95% CI, 2.08-131.37; P = .008, for 2LBs and 4LBs, respectively. Results on slippage were inconclusive. Adverse events were infrequent and did not differ significantly between interventions. Lower 6-month NHS costs for the combined population (£2413 vs. £2707 or £2648) and for newly diagnosed patients (£3045 vs. £3842 or £4480) were observed comparing 2LBA with 2LBB or 4LBA. Also, 2LBA was associated with better health-related quality of life (HRQoL) at 6 months., Conclusions: Based on these findings, 2LBA may result in lower treatment costs and better ulcer healing and HRQoL compared with other multicomponent therapies, especially in patients with newly diagnosed VLUs. However, further high-quality research is needed, especially for outcomes such as slippage and bandage wear time.

Purpose: To describe the revenue from a collaboration between a dedicated wound care center and an interventional radiology (IR) practice for venous leg ulcer (VLU) management at a tertiary care center., Materials and Methods: This retrospective study included 36 patients with VLU referred from a wound care center to an IR division during the 10-month active study period (April 2017 to January 2018) with a 6-month surveillance period (January 2018 to June 2018). A total of 15 patients underwent endovascular therapy (intervention group), whereas 21 patients did not (nonintervention group). Work relative value units (wRVUs) and dollar revenue were calculated using the Centers for Medicare and Medicaid Services Physician Fee Schedule., Results: Three sources of revenue were identified: evaluation and management (E&M), diagnostic imaging, and procedures. The pathway generated 518.15 wRVUs, translating to $37,522. Procedures contributed the most revenue (342.27 wRVUs, $18,042), followed by E&M (124.23 wRVUs, $8,881), and diagnostic imaging (51.65 wRVUs, $10,599). Intervention patients accounted for 86.7% of wRVUs (449.48) and 80.0% of the revenue ($30,010). An average of 33 minutes (38.3 hours total) and 2.06 hours (36.8 hours total) were spent on E&M visits and procedures, respectively., Conclusions: In this collaboration between the wound center and IR undertaken to treat VLU, IR and E&M visits generated revenue and enabled procedural and downstream imaging revenue., (Copyright © 2019 SIR. Published by Elsevier Inc. All rights reserved.)

Regardless of the amount of literature and evidence on leg ulcer management, there are still significant variations in treatment. Implementing a standardised leg ulcer pathway to ensure patients are appropriately and timely assessed could help reduce nursing time and overall costs, while improving healing outcomes and patients' quality of life. Such a pathway was introduced in Lincolnshire and Leicestershire, UK, to treat venous leg ulcers (VLUs). The results showed improved healing times, reduced costs and fewer nurse visits, among other findings.

Background: People with chronic venous insufficiency who develop leg ulcers face a difficult condition to treat. Venous leg ulcers may persist for long periods of time and have a negative impact on quality of life. Treatment requires frequent health care provider visits, creating a substantial burden across health care settings.The objective of this health technology assessment was to evaluate the effectiveness, safety, cost-effectiveness, budget impact, and patient experiences of compression stockings for prevention of venous leg ulcer recurrence., Methods: We conducted a systematic review of the literature to identify randomized trials and observational studies examining the effectiveness of compression stockings in reducing the risk of recurrence of venous leg ulcers after healing and/or reported on the quality of life for patients and any adverse events from the wearing of compression stockings. We performed a literature search to identify studies and evaluated the quality of the evidence using the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) approach.We conducted a cost-utility analysis with a 5-year time horizon from the perspective of the Ontario Ministry of Health and Long-Term Care. We compared compression stockings to usual care (no compression stockings) and simulated a hypothetical cohort of 65-year-old patients with healed venous ulcers, using a Markov model. Model input parameters were obtained primarily from the published literature. In addition, we used Ontario costing sources and consultation with clinical experts. We estimated quality-adjusted life years gained and direct medical costs. We conducted sensitivity analyses and a budget impact analysis to estimate the additional costs required to publicly fund compression stockings in Ontario. All costs are presented in 2018 Canadian dollars.We spoke to people who recently began using compression stockings and those who have used them for many years to gain an understanding of their day-to-day experience with the management of chronic venous insufficiency and compression stockings., Results: One randomized controlled trial reported that the recurrence rate was significantly lower at 12 months in people who were assigned to the compression stocking group compared with people assigned to the control group (risk ratio 0.43, 95% CI, 0.27-0.69; P = .001) (GRADE: Moderate). Three randomized controlled trials reported no significant difference in recurrence rates between the levels of pressure. One randomized controlled trial also reported that the risk of recurrence was six times higher in those who did not adhere to compression stockings than in those who did adhere. One single-arm cohort study showed that the recurrence rate was considerably higher in people who did not adhere or had poor adherence (79%) compared with those who adhered to compression stockings (4%).Compared with usual care, compression stockings were associated with higher costs and with increased quality-adjusted life years. We estimated that, on average, the incremental cost-effectiveness ratio of compression stockings was $27,300 per quality-adjusted life year gained compared to no compression stockings. There was some uncertainty in our results, but most simulations (> 70%) showed that the incremental cost-effectiveness ratio remained below $50,000 per quality-adjusted life-year. We estimated that the annual budget impact of funding compression stockings would range between $0.95 million and $3.19 million per year over the next five years.People interviewed commonly reported that chronic venous insufficiency had a substantial impact on their day-to-day lives. There were social impacts from the difficulty or inability to walk and emotional impacts from the loss of independence and fear of ulcer recurrence. There were barriers to the wearing of compression stockings, including replacement cost and the difficulty of putting them on; however, most people interviewed reported that using compression stockings improved their condition and their quality of life., Conclusions: The available evidence shows that, compared with usual care, compression stockings are effective in preventing venous leg ulcer recurrence and likely to be cost-effective. In people with a healed venous leg ulcer, wearing compression stockings helps to reduce the risk of recurrence by about half. Publicly funding compression stockings for people with venous leg ulcers would result in additional costs to the Ontario health care system over the next 5 years. Despite concerns about cost and the daily chore of wearing compression stockings, most people interviewed felt that compression stockings provided important benefits through reduction of swelling and prevention of recurrence.

Venous leg ulcers (VLUs) result in substantial economic costs and reduced quality of life (QoL); however, there are few Australian cost estimates, especially using patient-level data. We measured community-setting VLU management costs and the impact on the QoL of affected individuals. VLU patients were recruited from a specialist wound clinic, an outpatient clinic, and two community care clinics in Queensland. Cost data were collected at the baseline visit. QoL (EQ-5D-5L) and wound status data were collected at baseline, 1, 3, and 6 months. Patients were classified into guideline-based/optimal care and usual care groups. Average weekly costs per patient were statistically significantly different between the usual care and optimal care groups-$214.61 and $294.72, respectively (P = 0.04). Baseline average QoL score for an unhealed ulcer was significantly higher in the optimal care group compared with usual care (P = 0.025). Time to healing differed between the usual care group and the optimal care group (P = 0.04), with averages of 3.9 and 2.7 months, respectively. These findings increase the understanding of the costs, QoL, and healing outcomes of VLU care. Higher optimal care costs may be offset by faster time to healing. This study provides data to inform an economic evaluation of guideline-based care for VLUs., (© 2018 Medicalhelplines.com Inc and John Wiley & Sons Ltd.)

Background: Venous leg ulcers (VLUs) are expensive to treat and impair quality of life of affected individuals. Although improved healing and reduced recurrence rates have been observed following the introduction of evidence-based guidelines, a significant evidence-practice gap exists. Compression is the recommended first-line therapy for treatment of VLUs but unlike many other developed countries, the Australian health system does not subsidise compression therapy. The objective of this study is to estimate the cost-effectiveness of guideline-based care for VLUs that includes public sector reimbursement for compression therapy for affected individuals in Australia., Methods: A Markov model was designed to simulate the progression of VLU for patients receiving guideline-based optimal prevention and treatment, with reimbursement for compression therapy, and then compared to usual care in each State and Territory in Australia. Model inputs were derived from published literature, expert opinion, and government documents. The primary outcomes were changes to costs and health outcomes from a decision to implement guideline-based optimal care compared with the continuation of usual care. Sensitivity analyses were performed to test the robustness of model results., Results: Guideline-based optimal care incurred lower total costs and improved quality of life of patients in all States and Territories in Australia regardless of the health service provider. We estimated that providing compression therapy products to affected individuals would cost the health system an additional AUD 270 million over 5 years but would result in cost savings of about AUD 1.4 billion to the health system over the same period. An evaluation of unfavourable values for key model parameters revealed a wide margin of confidence to support the findings., Conclusions: This study shows that guideline-based optimal care would be a cost-effective and cost-saving strategy to manage VLUs in Australia. Results from this study support wider adoption of guideline-based care for VLUs and the reimbursement of compression therapy. Other countries that face similar issues may benefit from investing in guideline-based wound care.

Objective: To estimate the cost-effectiveness of an externally applied electroceutical (EAE) device, Accel-Heal, in treating non-healing venous leg ulcers (VLUs) in the UK., Method: This was a prospective, randomised, double-blind, placebo-controlled, multi-centre study of patients aged ≥18 years with a non-healing VLU. Patients were randomised in the ratio of 1:1 to receive six units of the EAE (consisting of a self-contained, programmed electric microcurrent generator and two skin contact pads) or an identical-looking placebo device over 12 consecutive days. Patients were followed-up for 24 weeks from randomisation, during which time patients received wound care according to the local standard care pathway, completed health-related quality of life (HRQoL) instruments, and health-care resource use was measured. The cost-effectiveness of the EAE device was estimated at 2015/16 prices in those patients who fulfilled the study's inclusion and exclusion criteria (economic analysis population)., Results: At 24 weeks after randomisation, 34% and 30% of VLUs in the EAE and placebo groups in the economic analysis population, respectively, had healed. The time-to-healing was a mean of 2.6 and 3.5 months in the EAE and placebo groups, respectively. The area of the wounds that healed in the EAE group was nearly twice that of those in the placebo group (mean: 13.3 versus 7.7cm 2 per VLU). Additionally, the pre-randomised duration of the wounds that healed in the EAE group was double that of those in the placebo group (mean: 2.6 versus 1.2 years per VLU). By the end of the study, EAE-treated patients reported less pain, more social functioning and greater overall wellbeing/satisfaction than placebo-treated patients. None of these differences reached statistical significance, but they may be important to patients. There were no significant differences in health-care resource use between the two groups. The incremental cost per quality-adjusted life year (QALY) gained with the EAE device was £4480 at eight weeks, decreasing to £2265 at 16 weeks and -£2388 (dominant) at 24 weeks. The study was confounded by unwarranted variation in patient management between centres and between individual clinicians within each centre., Conclusion: Despite the unwarranted variation in the provision of wound care observed in this study, the use of the EAE device resulted in some improved clinical outcomes and patient-reported outcomes, for the same or less cost as standard care, by 24 weeks. Clinicians managing VLUs may wish to consider the findings from this study when making treatment decisions.

Objective: Venous leg ulcers (VLUs) cause significant pain and suffering for patients. Additionally, they place considerable financial and service burden on the National Health Service (NHS). A large proportion of VLUs do not heal within the standard time frame of 16-24 weeks, resulting in static wounds which commonly have issues with increasing exudate production. As the NHS continues to face times of austerity, services need to find solutions to be able to reduce costs and release nursing time while maintaining standards of care. Cutimed Sorbion Sachet S, a hydration response technology dressing (HRTD), is a treatment option for the management of patients with a VLU. The objective of this study was to provide an update of the health economic analysis of HRTD in comparison with relevant comparators in the UK with current cost data., Method: HRTD was compared against four different dressings, Zetuvit Plus (a super absorbent polymer dressing SAP), DryMax extra (a superabsorbent dressing, SADM), KerraMax Care (superabsorbent dressing, SAKM) and Eclypse (superabsorbent dressing, SAE) from a cost-effectiveness perspective. Clinical data were derived from literature and expert opinion. Cost input was utilised based on publicly available data and literature. The average patient in the model is assumed to be 65 years with a diagnosed VLU. It is assumed that patients in the different treatment arms have the same background mortality, hence the endpoint mortality is not included in the model. The analysis is based on a deterministic Markov model derived from Harding et al. with weekly cycles. The following assumptions are made: first, all patients start in a static health state with a non-healed but non-progressing VLU. It is assumed in the model that patients wounds can transition to a deteriorating state or one where a wound is improving or could progress. Additionally, VLUs could be healed from a progressed wound (i.e. improved wound), or they could develop into a severe wound with complications (infections) to be treated in hospitals. The time frame for the analysis was fixed for one year and no re-occurence after healing was assumed to happen., Results: The cost-effectiveness analysis demonstrates health economic dominance of HRDT being more effective and cost-saving against all analysed comparators. When using literature-based input values, the incrementally higher healing rates for HRDT are 11.04 months (versus SAP), 29.04 months (versus SADM), 1.68 months (versus SAKM) and 11.04 months (versus SAE). Cost savings per patient were £37.60 versus SAP, £171.68 versus SADM, £3.13 versus SAKM and £43.63 versus SAE., Conclusion: Clinical benefits and cost savings increase when real-life practice assumptions, based on expert opinion, are included. Based on the underlying health economic model, HRDT is more effective and less costly than other comparative products in VLUs in the UK.

The aim of this study was to estimate the patterns of care and annual levels of health care resource use attributable to managing venous leg ulcers (VLUs) in clinical practice by the UK's National Health Service (NHS) and the associated costs of patient management. This was a retrospective cohort analysis of the records of 505 patients in The Health Improvement Network (THIN) Database. Patients' characteristics, wound-related health outcomes and health care resource use were quantified, and the total NHS cost of patient management was estimated at 2015/2016 prices. Overall, 53% of all VLUs healed within 12 months, and the mean time to healing was 3·0 months. 13% of patients were never prescribed any recognised compression system, and 78% of their wounds healed. Of the 87% who were prescribed a recognised compression system, 52% of wounds healed. Patients were predominantly managed in the community by nurses with minimal clinical involvement of specialist clinicians. Up to 30% of all the VLUs may have been clinically infected at the time of presentation, and only 22% of patients had an ankle brachial pressure index documented in their records. The mean NHS cost of wound care over 12 months was an estimated £7600 per VLU. However, the cost of managing an unhealed VLU was 4·5 times more than that of managing a healed VLU (£3000 per healed VLU and £13 500 per unhealed VLU). This study provides important insights into a number of aspects of VLU management in clinical practice that have been difficult to ascertain from other studies and provides the best estimate available of NHS resource use and costs with which to inform policy and budgetary decisions., (© 2017 Medicalhelplines.com Inc and John Wiley & Sons Ltd.)

Background: Chronic vascular wounds have a significant economic and social impact on our society calling for allocation of a great deal of attention and resources. Efforts should be oriented toward the achievement of the most effective and efficient clinical management. The Angiology Unit at the University Hospital of Padova, Italy, developed a performance improvement project to enhance the quality of practice for vascular ulcers., Methods: The project consisted in a multistep process comprising a critical revision of the previous clinical process management, staff education, tightening connections between operators and services, and creation of a position for a wound care nurse. The previous standard of practice was modified according to the results of revision and the current evidence-based practice., Results: The new standard of practice reached its full application in September 2015. The number of patients treated and the number of visits in 2015 remained almost unvaried from 2014. However, the total annual expenditure for treating vascular ulcers was reduced by ~60% from the previous year., Conclusion: Standardization of guidelines and practice is effective in creating an efficient clinical management and in reducing the economic burden of vascular ulcers., Competing Interests: Disclosure The authors report no conflicts of interest in this work.

Objective: To assess clinical outcomes and cost-effectiveness of using a two-layer cohesive compression bandage (TLCCB; Coban 2) compared with a two-layer compression system (TLCS; KTwo) and a four-layer compression system (FLCS; Profore) in treating newly-diagnosed venous leg ulcers (VLUs) in clinical practice in the UK, from the perspective of the NHS., Method: This was a retrospective cohort analysis of the case records of patients with newly-diagnosed VLUs randomly extracted from The Health Improvement Network (THIN) database (a nationally representative database of clinical practice among patients registered with general practitioners in the UK) who were treated with either TLCCB (n=200), TLCS (n=200) or FLCS (n=200). The clinical outcomes and cost-effectiveness of the alternative compression systems were estimated over six months after starting treatment., Results: Patients' mean age was 72 years and 58% were female. Time from wound onset to the start of compression was a mean of two months, and when starting compression the wound size was a mean of 45 cm 2 . The distribution of healing was significantly different between the three groups; 76% of wounds in the TLCCB group healed by six months compared with 70% and 64% in the TLCS and FLCS groups, respectively (p=0.006). Time to healing was significantly less in the TLCCB group compared with the two other groups (p=0.003). Patients in the TLCCB group experienced better health-related quality of life over six months (0.413 quality-adjusted life years (QALYs) per patient), compared with the TLCS and FLCS groups (0.404 and 0.396 QALYs per patient, respectively). The mean six-month NHS management cost was £3045, £3842 and £4480 per patient in the TLCCB, TLCS and FLCS groups, respectively., Conclusion: Real-world evidence demonstrates that treating newly-diagnosed VLUs with TLCCB, compared with the other two compression systems, affords a more cost-effective use of NHS-funded resources in clinical practice since it resulted in an increased healing rate, better health-related quality of life and a reduction in NHS management cost.

Chronic venous insufficiency is a prevalent disease that frequently leads to development of venous leg ulcers. While a number of evidence-based clinical practice guidelines have been developed that provide guidance for clinicians when caring for patients with chronic venous insufficiency, they lack adequate detail concerning selection and application of compression for prevention and management of venous leg ulcers. In order to address this need, the WOCN Society appointed a task force to develop an algorithm for compression for primary prevention, treatment, and prevention of recurrent venous leg ulcers in persons with chronic venous insufficiency. The task force used findings from a scoping literature review to identify current best evidence needed to support decision points and pathways within the algorithm. In addition, the task force convened a panel of 20 clinicians and researchers with expertise in lower extremity venous disorders in order to establish consensus around pathways and decision points within the algorithm lacking robust evidence. Following initial construction of the algorithm, a second interdisciplinary group of expert clinicians established content validity and provided additional qualitative feedback used to complete final revisions of the algorithm. This article reviews the process used to create this landmark algorithm, including generation of the evidence- and consensus-based statements used in its construction, the various pathways, and rich supplemental materials embedded within the algorithm, and the process used to establish content validity.

Chronic venous leg ulcers (VLUs) affect up to 1% of the adult population in the developed world and present a significant financial and resource burden to health care systems. Cadexomer iodine (CI) is an antimicrobial dressing indicated for use in chronic exuding wounds. The aim of this study was to estimate the cost utility of using CI + standard care (SC) - ie, high compression multicomponent bandaging including debridement - compared with SC alone in the management of chronic (>6 months' duration) VLUs from a payer's perspective. A Markov model was constructed to evaluate the cost and clinical benefits (healing and decreased infection rates) of the 2 treatment modalities over a 1-year period using data from 4 randomized, controlled clinical studies (RCTs) included in a recent Cochrane review and cost data from a recently published economic evaluation of VLUs. Costs were calculated using 2014 United States dollars; wound outcomes in- cluded complete healing in 212 patients reported in the Cochrane meta-analysis and quality-adjusted life years (QALYs), with utility values obtained from 200 patients with VLUs calculated using standard gamble. Treatment with CI over 1 year was $7,259 compared to $7,901 for SC. This resulted in a cost savings of $643/patient in favor of CI compared with SC. More patients treated with CI (61%) had their wounds healed compared to 54% treated with SC. Furthermore, patients treated with CI+SC experienced 6 additional ulcer-free weeks compared to persons treated with SC alone (ie, 25 ulcer- free weeks compared to 19 ulcer-free weeks, respectively). Overall, CI resulted in 0.03 more QALYs (ie, 0.86 QALYs compared to 0.83 for SC). The use of CI in addition to SC compared to SC alone over 52 weeks resulted in more wounds healed and more QALYs along with a decrease of overall costs The results of this study suggest CI is cost effective com- pared to SC alone in the management of patients with chronic VLUs. Prospective, controlled clinical studies are needed to elucidate the effect and cost effectiveness of CI on VLUs with and without signs of infection as compared to SC, other antiseptics, and more advanced topical treatment modalities.

The aim of this study was to determine the efficacy, safety and cost-effectiveness of an octenidine-based wound gel in the treatment of chronic venous leg ulcers. For this purpose, 49 wounds were treated with either modern wound-phase-adapted dressings alone (treatment arm 1; n = 17), octenidine wound gel plus modern wound-phase-adapted dressings (treatment arm 2; n = 17) or octenidine wound gel alone (treatment arm 3; n = 15). During the study period of 42 days with dressing changes every 3-5 days, wound healing characteristics and treatment costs of different dressings were analysed. Wound size reduction was significantly better (P = 0·028) in both octenidine wound gel treatment arms compared to modern dressings alone with total reductions of 14·6%, 64·1% and 96·2% in treatment arms 1-3. Early wound healing was merely observed under octenidine wound gel treatment (n = 9), whereby lowest treatment costs were generated by octenidine wound gel alone (€20·34/dressing change). As a result, the octenidine wound gel is cost-effective and well suitable for the treatment of chronic venous leg ulcers, considering both safety and promotion of wound healing., (© 2014 The Authors. International Wound Journal © 2014 Medicalhelplines.com Inc and John Wiley & Sons Ltd.)

Background: One of the most significant, and growing, challenges in modern medicine, i.e. the treatment of chronic wounds, is marked by nonuniform data. This concerns both prevalence and incidence of chronic dermatosis, in particular venous ulcers (ulcus cruris), as well as the impact on the health-related quality of life, and practical and economic parameters of the success of different therapies., Purpose: The aim of this work is to examine the epidemiology of chronic wounds, in particular age-associated venous ulcers, their impact on health-related quality of life, the treatment regimen, and practical and economic parameters of the success of different therapies., Materials and Methods: Performed were analysis of data on the care of venous ulcers in Germany, based on secondary data of Barmer GEK from 2009 and 2012, comparison with data of a NHS Kent Community Health Trust study, and analysis of studies concerning structures, processes and critical success factors for the treatment of chronic wounds, including economic effects., Conclusion: Early causal therapy with treatment based on the stage of the wound, consequent goal-oriented interdisciplinary care, and relapse prophylaxis is critical for successful healing of venous ulcers. The costs of treatment significantly correlate with the duration of treatment which can be reduced by up to 60% using guideline-based concepts for the treatment of chronic wounds. Treatment success, in particular with regard to cost-benefit considerations, can be optimized by telemedicine networks of key players who treat chronic wounds.

Although chronic wounds have a high socio-economic impact, data on comparative effectiveness of treatments are rare. UrgoStart(®) is a hydroactive dressing containing a nano-oligosaccharide factor (NOSF). This study aimed at evaluating the cost-effectiveness of this NOSF-containing wound dressing in vascular leg ulcers compared with a similar neutral foam dressing (UrgoCell(®) Contact) without NOSF. Cost-effectiveness analysis from the perspective of the German statutory health care system was performed using a decision tree model for a period of 8 weeks. Cost and outcome data were derived from the clinical study 'Challenge' suggesting a response rate (≥40% wound size reduction) of UrgoStart(®) of 65·6% versus 39·4% for the comparator. In the treatment model, effect-adjusted costs of €849·86 were generated after 8 weeks for treatment with UrgoStart(®) versus €1335·51 for the comparator resulting in an effect-adjusted cost advantage of €485·64 for UrgoStart(®) . In linear sensitivity analyses, the outcomes were stable for varying assumptions on prices and response rates. In an 8-week period of treatment for vascular leg ulcers, UrgoStart(®) shows superior cost-effectiveness when compared with the similar neutral foam dressing without any active component (NOSF). As demonstrated within a randomised, double-blind clinical trial, UrgoStart(®) is also more effective in wound area reduction than the neutral foam dressing. Wound healing was not addressed in this clinical trial. Follow-up data of 12 months to allow for reulceration assessment were not generated., (© 2014 The Authors. International Wound Journal © 2014 Medicalhelplines.com Inc and John Wiley & Sons Ltd.)

Management of chronic wounds remains unsatisfactory in terms of treatment cost and time required for complete wound closure (CWC).This study aimed to calculate the healing rates, estimated cost, and time required for CWC in wounds; compare estimated wound care costs between healing and nonhealing wounds; and compare cost effectiveness between venous leg ulcer (VLU) and non-VLU.This was a retrospective cohort study performed at a physical therapy (PT) wound care clinic. Deidentified patient data in the electronic medical database from September 10, 2012 to January 23, 2015 were extracted.Among 159 included patients with wounds, 119 (74.84%) patients were healed with CWC. The included patients were treated for 109.70 ± 95.70 days, 29.71 ± 25.66 visits, and at the costs per treatment episode of $1629.65 ± 1378.82 per reimbursement rate and $2711.42 ± 2356.81 per breakeven rate. For patients with CWC (healing group), the treatment duration was 98.01 ± 76.12 days with the time for CWC as 72.45 ± 64.21 days; the cost per treatment episode was $1327.24 ± 1143.53 for reimbursement rate and $2492.58 ± 2106.88 for breakeven cost. For patients with nonhealing wounds, treatment duration was found to be longer with costs significantly higher (P < 0.01 for all). In the healing group, no differences were found between VLU and non-VLU in treatment duration (95.46 days vs. 100.88 days, P = 0.698), time for CWC (68.06 days vs. 77.38 days, P = 0.431), and cost ($2756.78 vs. 2397.84 for breakeven rate, P = 0.640) with the exception of wound dressing costs ($329.19 vs. 146.47, P = 0.001).Healing rates may be affected with patient exclusions. Costs at physicians' offices were not included.Incorporation of PT in wound care appeared to be cost effective. PT may thus be a good referral option for patients with wounds. However, the results should be interpreted cautiously and further studies are warranted., Competing Interests: The authors have no funding and conflicts of interest to disclose.

Background: Venous leg ulcers are common, chronic wounds that are painful and reduce quality of life. Compression therapy is known to assist in the healing of venous leg ulceration. Supervised exercise training that targets an improvement in calf muscle pump function might be a useful adjunctive therapy for enhancing ulcer healing and other aspects of physical and mental health. However, the evidence of exercise for individuals with venous ulcers is sparse. Here, we describe the protocol for a study that aims to assess the feasibility of undertaking a randomised controlled trial of a supervised exercise programme in people who are receiving compression for venous ulceration., Methods/design: This is a randomised, controlled, assessor-blinded, two-centre, feasibility trial with two parallel groups. Eighty adults who are receiving lower-limb compression for a venous leg ulcer will be randomly assigned to receive usual care (compression only) or usual care plus a 12-week supervised exercise programme. Participants in the exercise group will be invited to undertake three, 60-minute sessions of supervised exercise each week, and each session will involve a combination of treadmill walking, upright cycling and strength and flexibility exercises for the lower limbs. Participants will be assessed before randomisation and 3, 6 and 12 months after randomisation. Primary outcomes include rates of recruitment, retention and adherence. Secondary outcomes include time to ulcer healing, proportion of participants healed, percentage and absolute change in ulcer size, health-related quality of life (EQ-5D-5L and VEINES-QOL/Sym), lower-limb cutaneous microvascular function (laser Doppler flowmetry coupled with iontophoresis) and physical fitness (30-second sit-to-stand test, chair sit and reach test, 6-minute walk test and ankle range of motion). The costs associated with the exercise programme and health-care utilisation will be calculated. We will also complete interviews with a sub-sample of participants to explore their experiences of having a venous ulcer and the acceptability of the exercise intervention and study procedures., Discussion: Data from this study will be used to refine the supervised exercise programme, investigate the acceptability of the intervention and study design and determine the most appropriate outcome measures, thereby providing estimates of the factors needed to design an adequately powered trial across several centres., Trial Registration: Current Controlled Trials, ISRCTN10205425 (May 2014) - http://www.controlled-trials.com/ISRCTN10205425.

Adequate nutrition has long been considered a critical component for wound healing, but literature regarding the relationship between nutrition and venous ulcer (VU) healing is limited. A person's nutrition is affected by the availability of food as well as his/her overall health. Food sufficiency and nutrition are important concerns in the care of persons of low income with injection-related VUs, which tend to be large and slow to heal. A cross-sectional pilot study was conducted to explore the relationship between food sufficiency/security and nutrition with regard to demographic, wound, quality-of-life, physical activity, falls, and fall risk variables. Nutrition was examined using 2 well-developed instruments that measure food sufficiency/security and assess nutrition--the United States Department of Agriculture's Adult Food Sufficiency Questionnaire (FSQ) and the Nestle Mini Nutritional Assessment (MNA). All participants (N = 31, 54% men, mean age 56.1 ± 3.6 years, all African American) were recruited from an outpatient clinic. All had injection-related VUs from a history of injecting illicit substances. In terms of food sufficiency/security, most participants (26, 84%) reported having enough food in the house, but 10 (32%) worried about running out of food. From 16% to 22.6% of participants expressed concern with food sufficiency/security in terms of cutting meal size, eating less, hunger, and weight loss. Food sufficiency/security was high for 19 (61.3%), but 12 (39%) had marginal or lower food sufficiency/security. MNA scores showed 16 participants (52%) were at risk of malnutrition or malnourished. Low food sufficiency/security was significantly (P <0.05) associated with less motivation for activity (r = -0.40) and less walking (r = -0.36). Better nutrition assessment scores were significantly associated (P <0.01) with fewer comorbidities (r = -0.57) and falls (r = -0.46) and with higher quality of life (r = 0.50), motivation for physical activity (r = 0.59), and balance confidence (r = 0.60). Both food security and nutrition assessment are important to assess in low-income persons with injection-related VUs. A number of significant relationships of the FSQ and MNA to other variables was found but needs further investigation with a larger sample.

Objective: Massive (≥100 cm(2)) venous leg ulcers (VLUs) demonstrate very low closure rates with standard compression therapy and are costly to manage. Negative-pressure wound therapy (NPWT), followed by a split-thickness skin graft (STSG), can be a cost-effective alternative to this standard care. We performed a cost analysis of these two treatments., Methods: A retrospective review was performed of 10 ulcers treated with surgical debridement, 7 days of inpatient NPWT with topical antiseptic instillation (NPWTi), and STSG, with 4 additional days of inpatient NPWT bolster over the graft. Independent medical cost estimators were used to compare the cost of this treatment protocol with standard outpatient compression therapy., Results: The average length of time ulcers were present before patients entered the study was 38 months (range, 3-120 months). Eight of 10 patients had complete VLU closure by 6 months after NPWTi with STSG. The 6-month costs of the proposed treatment protocol and standard twice-weekly compression therapy were estimated to be $27,000 and $28,000, respectively., Conclusions: NPWTi with STSG treatment is more effective for closure of massive VLUs at 6 months than that reported for standard compression therapy. Further, the cost of the proposed treatment protocol is comparable with standard compression therapy., (Copyright © 2015 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Venous ulcer is a common vascular condition affecting 1% of the population, and a prevalence that increases with age. Venous ulcer is defined by the American Venous Forum as "a full-thickness defect of skin, most frequently in the ankle region, that fails to heal spontaneously and is sustained by chronic venous disease, based on venous duplex ultrasound testing." The economic and social burden of this condition is significant to both the affected individual and the health care system. The recurrent nature of venous ulcers underscore the need for treatment of the underlying pathophysiology, that is, ambulatory venous hypertension produced by venous valve reflux alone or in conjunction with venous obstruction., (Copyright © 2015 Elsevier Inc. All rights reserved.)

Objectives: Determine the cost-effectiveness of three topically applied cellular/tissue-derived products (CTPs) used as adjunct therapies to standard care in the management of venous leg ulcers (VLUs)., Methods: A three-state Markov model derived from the medical literature was developed to estimate the comparative cost-effectiveness of three CTPs in relation to VLU standard care. CTPs evaluated in the study included extracellular matrix (ECM), human skin equivalent (HSE), and living skin equivalent (LSE). The three Markov states included unhealed, healed, and death. A 1-year time horizon was used to determine the number of ulcer-free weeks and the expected costs of therapies. The payer perspective was taken in the analysis and only the direct costs of care were considered. Sensitivity analyses were performed to gauge model parameter uncertainty., Results: The expected costs for standard care, ECM, HSE, and LSE VLU therapy were $6,132, $6,732, $10,638, and $11,237, while the expected outcomes were 24, 31, 29, and 27 ulcer-free weeks, respectively. ECM was economically dominant among the three CTPs. In the base case of ECM versus standard care, the incremental cost-effectiveness ratio for ECM therapy was $86 per ulcer-free week. Sensitivity analysis did not alter ECM dominance. Clinic visits and home health utilization exhibited the greatest influence on cost., Conclusions: ECM is the most cost-effective CTP when used in the management of VLUs as an adjunct to standard care. These findings suggest that VLU standard care therapy with ECM can yield potential cost savings and produce better outcomes than do other CTPs., (Copyright © 2014 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.)

Background: Compression is an effective and recommended treatment for venous leg ulcers. Although the four-layer bandage (4LB) is regarded as the gold standard compression system, it is recognised that the amount of compression delivered might be compromised by poor application technique. Also the bulky nature of the bandages might reduce ankle or leg mobility and make the wearing of shoes difficult. Two-layer compression hosiery systems are now available for the treatment of venous leg ulcers. Two-layer hosiery (HH) may be advantageous, as it has reduced bulk, which might enhance ankle or leg mobility and patient adherence. Some patients can also remove and reapply two-layer hosiery, which may encourage self-management and could reduce costs. However, little robust evidence exists about the effectiveness of two-layer hosiery for ulcer healing and no previous trials have compared two-layer hosiery delivering 'high' compression with the 4LB., Objectives: Part I To compare the clinical effectiveness and cost-effectiveness of HH and 4LB in terms of time to complete healing of venous leg ulcers. Part II To synthesise the relative effectiveness evidence (for ulcer healing) of high-compression treatments for venous leg ulcers using a mixed-treatment comparison (MTC). Part III To construct a decision-analytic model to assess the cost-effectiveness of high-compression treatments for venous leg ulcers., Design: Part I A multicentred, pragmatic, two-arm, parallel, open randomised controlled trial (RCT) with an economic evaluation. Part II MTC using all relevant RCT data - including Venous leg Ulcer Study IV (VenUS IV). Part III A decision-analytic Markov model., Settings: Part I Community nurse teams or services, general practitioner practices, leg ulcer clinics, tissue viability clinics or services and wound clinics within England and Northern Ireland., Participants: Part I Patients aged ≥ 18 years with a venous leg ulcer, who were willing and able to tolerate high compression., Interventions: Part I Participants in the intervention group received HH. The control group received the 4LB, which was applied according to standard practice. Both treatments are designed to deliver 40 mmHg of compression at the ankle. Part II and III All relevant high-compression treatments including HH, the 4LB and the two-layer bandage (2LB)., Main Outcome Measures: Part I The primary outcome measure was time to healing of the reference ulcer (blinded assessment). Part II Time to ulcer healing. Part III Quality-adjusted life-years (QALYs) and costs., Results: Part I A total of 457 participants were recruited. There was no evidence of a difference in time to healing of the reference ulcer between groups in an adjusted analysis [hazard ratio (HR) 0.99, 95% confidence interval (CI) 0.79 to 1.25; p = 0.96]. Time to ulcer recurrence was significantly shorter in the 4LB group (HR = 0.56, 95% CI 0.33 to 0.94; p = 0.026). In terms of cost-effectiveness, using QALYs as the measure of benefit, HH had a > 95% probability of being the most cost-effective treatment based on the within-trial analysis. Part II The MTC suggests that the 2LB has the highest probability of ulcer healing compared with other high-compression treatments. However, this evidence is categorised as low to very low quality. Part III Results suggested that the 2LB had the highest probability of being the most cost-effective high-compression treatment for venous leg ulcers., Conclusions: Trial data from VenUS IV found no evidence of a difference in venous ulcer healing between HH and the 4LB. HH may reduce ulcer recurrence rates compared with the 4LB and be a cost-effective treatment. When all available high-compression treatments were considered, the 2LB had the highest probability of being clinically effective and cost-effective. However, the underpinning evidence was sparse and more research is needed. Further research should thus focus on establishing, in a high-quality trial, the effectiveness of this compression system in particular., Trial Registration: Current Controlled Trials ISRCTN49373072., Funding: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 18, No. 57. See the NIHR Journals Library website for further project information.

Chronic wounds are rising in prevalence and creating significant socioeconomic burdens for patients and healthcare systems worldwide. Therefore, it is now more important than ever that clinicians follow evidence-based guidelines for wound care when developing personalized treatment plans for their patients with chronic wounds. Evidence-based guidelines for treating venous leg ulcers, diabetic foot ulcers, and pressure ulcers, the 3 main categories of chronic wounds, focus primarily on biologic therapies. However, there are also evidence-based guidelines for treating behavioral risks to poor healing, such as smoking, which should be incorporated into treatment plans when appropriate. The purpose of this article was to review the mechanisms through which smoking adversely impacts the wound healing process, and propose strategies for incorporating evidence-based guidelines for treating tobacco dependence into treatment plans for patients with chronic wounds who smoke.

Aim: To estimate the cost-effectiveness of silver dressings using a health economic model based on time-to-wound-healing in hard-to-heal chronic venous leg ulcers (VLUs)., Background: Chronic venous ulceration affects 1-3% of the adult population and typically has a protracted course of healing, resulting in considerable costs to the healthcare system. The pathogenesis of VLUs includes excessive and prolonged inflammation which is often related to critical colonisation and early infection. The use of silver dressings to control this bioburden and improve wound healing rates remains controversial., Methods: A decision tree was constructed to evaluate the cost-effectiveness of treatment with silver compared with non-silver dressings for four weeks in a primary care setting. The outcomes: 'Healed ulcer', 'Healing ulcer' or 'No improvement' were developed, reflecting the relative reduction in ulcer area from baseline to four weeks of treatment. A data set from a recent meta-analysis, based on four RCTs, was applied to the model., Results: Treatment with silver dressings for an initial four weeks was found to give a total cost saving (£141.57) compared with treatment with non-silver dressings. In addition, patients treated with silver dressings had a faster wound closure compared with those who had been treated with non-silver dressings., Conclusion: The use of silver dressings improves healing time and can lead to overall cost savings. These results can be used to guide healthcare decision makers in evaluating the economic aspects of treatment with silver dressings in hard-to-heal chronic VLUs.

An Excel model was developed to compare total costs (including primary and secondary dressings only) of Hydrofiber(®) ; dressing (2010 branded price) versus an alginate dressing (generic or branded price) in managing exuding venous leg ulcers considering mean wear time and mean duration of exudate management phase, from the French Social Security perspective over 5 years (2011-2015). Budget impact (based on prevalence of venous leg ulcers in France) was estimated as the difference between scenario 1 (Hydrofiber(®) ; versus alginate dressing usage proportion increasing slightly per year) and Scenario2 (proportion remaining at 2010 levels). Annual costs and net savings per patient for the dressings were calculated in analyses 1 and 2. Analysis 1 (28-day mean exudate management phase for both Hydrofiber(®) ; and alginate dressing groups): total costs 66·82€ Hydrofiber(®) ;, 70·08€ generic alginate, 77·0€ branded alginate; net savings 3·26€ and 10·18€ for Hydrofiber(®) ; versus generic and branded alginate. Analysis 2 (mean exudate management phase of 22·2 versus 28 days for Hydrofiber(®) ; versus alginate): total costs 52·92€, 70·08€ and 77·0€, and net savings 17·10€ and 24·02€, accordingly. Total cost savings (budget impact scenario 1 minus scenario 2): Analysis 1 - 223 107€ and 696 304€ for Hydrofiber(®) ; versus generic and branded alginate dressings, respectively; Analysis 2 - 1 169 845€ and 1 643 042€ accordingly. Sensitivity analyses indicated that results are reliable. This conservative analysis shows that effective exudate management using Hydrofiber(®) ; dressing can produce sizeable cost savings., (© 2012 The Authors. International Wound Journal © 2012 Medicalhelplines.com Inc and John Wiley & Sons Ltd.)

Background: Four-layer bandaging is the standard treatment for venous leg ulcers but is bulky and can restrict mobility. Two-layer compression stockings have recently been marketed but their clinical and cost effectiveness were unknown., Aim: To compare the clinical and cost effectiveness of four-layer bandaging with two-layer compression stockings., Method: In a pragmatic, open, randomised controlled trial 454 participants were randomly allocated two-layer compression stockings or four-layer bandages and followed for up to 12 months after healing., Results: The median time to ulcer healing was almost identical (stockings group: 99 days, bandaging group: 98 days). More patients allocated stockings changed treatment but ulcer recurrence rates were higher in the bandaging group. Stockings cost 302 sterling pounds less per participant per year and had more than 95% probability of being the most cost-effective treatment., Conclusion: Two-layer compression stockings are a viable, cost-effective alternative to four-layer bandaging but may not be suitable for all patients.

Background: Drawbacks exist with the standard treatment (four-layer compression bandages) for venous leg ulcers. We have therefore compared the clinical effectiveness and cost-effectiveness of two-layer compression hosiery with the four-layer bandage for the treatment of such ulcers., Methods: We undertook this pragmatic, open, randomised controlled trial with two parallel groups in 34 centres in England and Northern Ireland. The centres were community nurse teams or services, family doctor practices, leg ulcer clinics, tissue viability clinics or services, and wound clinics. Participants were aged 18 years or older with a venous leg ulcer and an ankle brachial pressure index of at least 0·8, and were tolerant of high compression. We randomly allocated participants (1:1) to receive two-layer compression hosiery or a four-layer bandage, using a remote randomisation service and prevalidated computer randomisation program. Participants were stratified by ulcer duration and ulcer area with permuted blocks (block sizes four and six). The primary endpoint was time to ulcer healing, with a maximum follow-up of 12 months. Although participants and health-care providers were not masked to treatment allocation, the primary endpoint was measured by masked assessment of photographs. Primary analysis was intention to treat with Cox regression, with adjustment for ulcer area, ulcer duration, physical mobility, and centre. This trial is registered with the ISRCTN register, number ISRCTN49373072., Findings: We randomly allocated 457 participants to the two treatment groups: 230 to two-layer hosiery and 227 to the four-layer bandage, of whom 453 (230 hosiery and 223 bandage) contributed data for analysis. Median time to ulcer healing was 99 days (95% CI 84-126) in the hosiery group and 98 days (85-112) in the bandage group, and the proportion of ulcers healing was much the same in the two groups (70·9% hosiery and 70·4% bandage). More hosiery participants changed their allocated treatment (38·3% hosiery vs 27·0% bandage; p=0·02). 300 participants had 895 adverse events, of which 85 (9·5%) were classed as serious but unrelated to trial treatment., Interpretation: Two-layer compression hosiery is a viable alternative to the four-layer bandage-it is equally as effective at healing venous leg ulcers. However, a higher rate of treatment changes in participants in the hosiery group than in the bandage group suggests that hosiery might not be suitable for all patients., Funding: NIHR Health Technology Assessment programme (07/60/26)., (Copyright © 2014 Elsevier Ltd. All rights reserved.)

Lower leg ulcers is the most common form of ulceration of the lower extremities. The prevalence of leg ulcer varies among studies from 0.1% to 0.6%. In the majority of studies, 1% of the population develop leg ulcer at least once in lifetime. The prevalence is higher in elderly people. There are several hypotheses used to explain the pathophysiological steps leading from the popliteal venous hypertension in value. Currently, the treatment of leg ulcer relies on due knowledge of ulcer pathophysiology and making an accurate diagnosis. Venous disease has a significant impact on quality of life and work productivity. In addition, costs associated with the prevention and treatment of lower leg ulcers are significant.

Venous leg ulcers affect up to 3% of people aged 65 years and older, present significant pain and suffering, and are associated with long episodes of health care. These chronic wounds recur at rates of up to 69%. A double blind randomized controlled trial was conducted in a home nursing setting in Victoria, Australia to compare the effectiveness of a 23 to 32 mm Hg (moderate) and a 34 to 46 mm Hg (high) compression stocking treatment on venous ulcer recurrence. Participants (n = 100) were monitored for 26 weeks. Study wound recurrence was low (11.8%), and the average time to recurrence was 77.91 days. Adherence to treatment was low (44%) with nonadherence significantly higher in the high-compression stocking group, χ(2)(1) = 8.827, P = .003. Regression modeling found that adherence to treatment significantly predicted study wound recurrence, Wald(1) = 7.917, P = .005. Estimated hazard ratios showed that participants who did not adhere were 9 times more likely to have their wound recur. Risk of recurrence was 3 times greater for those randomized to moderate compression when compared with the high-compression stocking. Implementing strategies that optimize adherence to compression will reduce ulcer recurrence. Once this has been realized, the potential to adhere to high-compression treatment would further reduce the risk of recurrence.

Background: Today numerous products for wound care are available. A research-based evidence on which the clinician can base its selection, is still missing. In the guidelines randomized controlled trials (RCTs) have been left out., Method: In the overview three current RCT with products for the treatment of chronically venous ulcers will be presented., Results and Conclusions: The pre-mentioned studies show, that it is possible to provide a basis for evidence-based treatment in wound healing. The effective value ofa wound treatment based on the costs and benefits must be defined by the health system. But products, for which data from randomized trials exist, should be evaluated in a different way to products, for which there are no such data.

Chronic venous ulcers (CVUs) occur in approximately 1% of the general population. Risk factors for chronic venous disease (CVD) include heredity, age, female sex and obesity. Although not restricted to the elderly, the prevalence of CVD, especially leg ulcers, increases with age. CVD has a considerable impact on health-care resources. It has been estimated that venous ulcers cause the loss of approximately two million working days and incur treatment costs of approximately $3 billion per year in the USA. Overall, CVD has been estimated to account for 1-3% of the total health-care budgets in countries with developed health-care systems. The pathophysiology of dermal abnormalities in CVU is reflective of a complex interplay that involves sustained venous hypertension, inflammation, changes in microcirculation, cytokine and matrix metalloproteinase (MMP) activation, resulting in altered cellular function and delayed wound healing.

The aim of the study was to determine the demand on health service utilisation and to estimate the therapeutical costs caused by patients with chronic leg ulcer (CLU) in German primary care. A population-based case-control study was conducted using electronic medical records of 116 059 patients extracted from the CONTENT primary care database of Heidelberg, Germany, between April 2007 and March 2010. The drug and non drug prescription rates among patients with CLU were analysed by means of a unified German identification key and compared with those of patients with chronic venous insufficiency (CVI) without CLU. In the 3-year-contact group, CLU patients had significantly more patient-doctor encounters (55·9 versus 40·3; p < 0·0001), more referrals to home-care services (6·12 versus 3·08; p < 0·0001), and more admissions to hospitals (0·9 versus 0·4; p < 0·0001) than CVI patients, but no difference in referrals to specialists. The annual treatment costs for drugs and non drugs in CLU patients were substantially higher than in CVI patients (1645·75 € versus 1188·17 €; p < 0·0001). Wound dressings were identified as the most cost-enlarging factor. Summarising, CLU patients in primary care settings place a higher demand on health service utilisation and need nearly one-third higher therapeutical costs compared to venous patients without ulceration., (© 2012 The Authors. International Wound Journal © 2012 Blackwell Publishing Ltd and Medicalhelplines.com Inc.)

Background: Venous leg ulcers, affecting approximately 1% of the population, are costly to manage due to poor healing and high recurrence rates. We evaluated an evidence-informed leg ulcer care protocol with two frequently used high compression systems: 'four-layer bandage' (4LB) and 'short-stretch bandage' (SSB)., Methods: We conducted a cost-effectiveness analysis using individual patient data from the Canadian Bandaging Trial, a publicly funded, pragmatic, randomized trial evaluating high compression therapy with 4LB (n = 215) and SSB (n = 209) for community care of venous leg ulcers. We estimated costs (in 2009-2010 Canadian dollars) from the societal perspective and used a time horizon corresponding to each trial participant's first year., Results: Relative to SSB, 4LB was associated with an average 15 ulcer-free days gained, although the 95% confidence interval [-32, 21 days] crossed zero, indicating no treatment difference; an average health benefit of 0.009 QALYs gained [-0.019, 0.037] and overall, an average cost increase of $420 [$235, $739] (due to twice as many 4LB bandages used); or equivalently, a cost of $46,667 per QALY gained. If decision makers are willing to pay from $50,000 to $100,000 per QALY, the probability of 4LB being more cost effective increased from 51% to 63%., Conclusions: Our findings differ from the emerging clinical and economic evidence that supports high compression therapy with 4LB, and therefore suggest another perspective on high compression practice, namely when delivered by trained registered nurses using an evidence-informed protocol, both 4LB and SSB systems offer comparable effectiveness and value for money.