Search

Aim: The study was designed to generate real‐world evidence on IDegLira in the Italian clinical practice in two groups of patients with type 2 diabetes (T2D), switching to IDegLira either from a basal only (basal group) or basal‐bolus insulin regimen (BB group). Materials and Methods: This was a non‐interventional, multicentre, single‐cohort, prospective study assessing the long‐term glycaemic control in patients with T2D, who switched to IDegLira from a basal insulin ± glucose‐lowering medication regimen with or without a bolus insulin component for approximately 18 months, conducted in 28 Italian diabetes centres. The primary endpoint was the change in glycated haemoglobin (HbA1c) levels from baseline to 6 months after IDegLira initiation. Results: The study included 358 patients with a mean age 67.2 years and diabetes duration of 15.7 years. HbA1c significantly decreased from IDegLira start to all study time points in the overall population (basal group −1.19%; BB group −0.60% at the end of observation). Patients achieving HbA1c <7% levels increased from 12.9% (n = 43) to 40.3% (n = 110) at 18 months. Fasting blood glucose and body weight also significantly decreased in both groups, although more in the BB group. Overall, 14.3% of completed patients had an intensification of treatment (mainly in the basal group) and 48.6% had a simplification of treatment (mainly in the BB group). Conclusions: Switching to IDegLira in a real‐world clinical setting is a valid therapeutic option for patients with T2D with inadequate glycaemic control on basal or BB insulin regimen and/or need to simplify their insulin therapy, with specific reasons and therapeutic goals according to different T2D management trajectories. [ABSTRACT FROM AUTHOR]

Chronic limb-threatening ischemia (CLTI) represents the end-stage form of peripheral arterial disease (PAD) and is associated with a very poor prognosis and high risk of limb loss and mortality. It can be considered very similar to a terminal cancer disease, reflecting a large impact on quality of life and healthcare costs. The aim of this study is to offer an overview of the relationship between CLTI, limb salvage, and mortality, with a focus on the need of a fast-track team-based management that is a driver to achieve better survival results. This review can be useful to improve management of this growing impact disease, and to promote the standardisation of care and communication between specialist and non-specialist healthcare professionals. [ABSTRACT FROM AUTHOR]

Chronic kidney disease (CKD) is one of the most common complications of diabetes mellitus and an independent risk factor for cardiovascular disease. Despite guideline-directed therapy of CKD in patients with type 2 diabetes, the risk of renal failure and cardiovascular events still remains high, and diabetes remains the leading cause of end-stage kidney disease in affected patients. To date, current medications for CKD and type 2 diabetes mellitus have not reset residual risk in patients due to a high grade of inflammation and fibrosis contributing to kidney and heart disease. This question-and-answer-based review will discuss the pharmacological and clinical differences between finerenone and other mineralocorticoid receptor antagonists and then move on to the main evidence in the cardiovascular and renal fields, closing, finally, on the potential role of therapeutic combination with sodium-glucose cotransporter 2 inhibitors (SGLT2is). [ABSTRACT FROM AUTHOR]

Purpose: Infection, which is one of the possible complications of diabetic foot ulcers (DFUs), makes the treatment of ulcers challenging because of its negative impact on healing processes and the high prevalence of multiresistant germs. This study is aimed at verifying the effect of a surgical CO2 laser (which reduces the bacterial load and allows a more accurate debridement), as compared with the traditional lancets, on the healing rate of DFU. Methods: The present case-control retrospective analysis was performed on patients with chronic (>6 months) DFU with Texas grade >1, treated with 80 W surgical CO2 laser (DEKA SmartXide2 C80, El.En. Group) and compared with a matched sample of patients with similar characteristics, who were treated with a traditional surgical approach. The debridement was performed trying to achieve the complete removal of nonviable tissues. The principal endpoint was the proportion of patients healed at 6 months. All analyses were carried out with SPSS 25.0. The study protocol was approved by the local ethical committee. Results: This study included 118 patients (59 cases and 59 controls). At 6 months, the proportion of healing patients was 35% and 18% in cases and controls, respectively (P =.034). The corresponding figure at 1 year was 62% and 38% (P =.009), whereas no difference was observed at 1, 2, and 3 months. No serious adverse event was observed. Conclusions: In this article, we show for the first time that CO2 laser treatment, in comparison with traditional surgical approaches, can be associated with an increased healing rate in patients with DFU. [ABSTRACT FROM AUTHOR]

The safety and efficacy of a novel superoxidized solution (Dermacyn™ Wound Care [DWC], Oculus Innovative Sciences, Petaluma, Calif) was evaluated for the treatment of wide postsurgical infected ulcers of the [...]

Aims: Sodium glucose co‐transport‐2 (SGLT‐2) inhibitors reduce tubular glucose reabsorption, producing a reduction of blood glucose without stimulating insulin release. The aim of this meta‐analysis was the systematic collection of available data from randomized trials, in order to establish the durability of the efficacy of SGLT‐2 inhibitors on glycaemic control and body mass index. Methods: A meta‐analysis was performed, including all trials with a duration of at least 12 weeks, comparing SGLT‐2 inhibitors with non‐SGLT‐2 inhibitor agents in type 2 diabetes. The principal outcome was the effect of SGLT‐2 inhibitors on hemoglobin A1c (HbA1c) at 12, 24, 52 and 104 weeks. Data on body mass index at the same time points were also collected. Results: Among 66 randomized trials, HbA1c reduction at 12, 24, 52 and 104 weeks was 0.63% (0.57; 0.68, 0.63% (0.57; 0.70), 0.66% (0.57; 0.74) and 0.60% (0.40; 0.81), respectively. SGLT‐2 inhibitors showed a greater efficacy than dipeptidyl‐peptidase‐4 inhibitors (DPP‐4i). Sulfonylureas appeared to be superior to SGLT‐2 inhibitors at 12 weeks, but not at 24 and 52 weeks; SGLT‐2 inhibitors produced a greater reduction in HbA1c than did sulfonylureas at 104 weeks. SGLT‐2 inhibitor‐induced weight loss in placebo‐controlled trials appeared to increase progressively with the duration of treatment. Conclusions: SGLT‐2 inhibitors showed a good persistence of efficacy, at least up to 2 years, with a small but significant superiority over DPP‐4i. Sulfonylureas are more effective in the very short term, but less effective in the longer term. [ABSTRACT FROM AUTHOR]

Aim: Not revascularised critical limb ischaemia (no-CLI) is affected by a high amputation rate (30% at one year) and high mortality rate (50% at one year). Treatment with autologous peripheral blood mononuclear cells (A-PBMNC) showed promising outcomes in limb salvage and survival rate. A-PBMNC implants are performed in the leg and the perilesional area with a 21 G needle, extremely painful also for neuropathic patients, repeated a maximum of three times. If necessary, foot surgery was performed at the same time as the last implant. In the study we evaluated long-term outcomes and retrospectively compared patient clinical parameters and surgeon comfort in a group treated with deep sedation (DS) in spontaneous breathing and a group treated with popliteal and saphenous block (PSB) under ultrasound guidance. Method: We evaluated 102 diabetic no-CLI patients with similar baseline features and indications who underwent 288 A-PBMNC implants from January 2017 to September 2022: 42 patients with DS (122 implants) and 60 with PSB (166 implants). During the implants all patients underwent no invasive hemodynamic monitoring (blood pressure, heart rate, oxygen saturation) and the post-operative NRS scale. Surgeon comfort as akinesia and side effects are reported. The minimum follow-up period was 12 months. Results / Discussion: During the procedures, SD determined a higher variation in blood pressure (±20 mmHg), heart rate (±20 bpm) and oxygen saturation (±5 mmHg) than in PSB, respectively 35 vs 26; 97 vs 33; 10 vs 7. In 160 PSB procedures, sufficient anaesthesia and akinesia were achieved, but in 6 cases we need to adjunct SD. Only in 32 SD procedures akinesia was achieved. The mean surgical time was 35.7 minutes. After the procedure, each PSB patient was asked to indicate his value on the VAS pain scale (2.4±0,8 during the process; 2.2±0,3 after). No side effects were registered. Sixty-nine patients completed at least a one-year follow-up alive and without recurrences; five patients achieved a five years follow-up, 17 patients a four years follow-up; six patients a three years follow-up; five patients a two-year and 26 patients a 1-year follow-up. The healing rate at the 12-month follow-up was 68% (69/102), and the recurrences rate was 7,2% (5/69). In patients in remission, the mean ulcer-free survival days was 946,4±521,26, and the median ulcer-free survival days was 594,55. The overall mortality rate was 32,3% (33/102). The overall amputation rate was 10.7% (11/102). Conclusion: In A-PBMNC implants, the choice of the best anaesthesia regimen remains an open question and PSB showed to be more effective and as safe as SD. In the long-term follow-up, A-PBMNC therapy effectively improves limb salvage, survival rate, long-term management and remission parameters in diabetic no-CLI patients. [ABSTRACT FROM AUTHOR]

Aim: Postoperative wounds may arise from several etiologies including open partial pedal amputation, postoperative infection, and dehiscence of surgical sites from wound failure or patient compliance issues. If negative pressure wound therapy is the gold standard, its application in the toes area could be challenging as a consequence standard care is most likely used. Reactive oxygen species are a key part of the normal wound-healing process and we evaluate the use of a new oxygen-enriched oil-based product (gROS) in this kind of ulcers. Method: A total of 22 diabetic patients with tunnelling post-surgical dehiscence of the foot (TUC IIA or IIIA) comprised the study population. Patients were randomised in two groups as follows: group 1 patients were treated with (gROS) and group 2 patients were treated with standard therapy. Primary outcome is healing rate. Secondary outcomes are new infections and side effects. Results / Discussion: After 16 weeks wound closure occurred in 9 patients (75%) in group 1 and 4 (33%) in group 2 (p=0,04). New infections affected 2 patients (17%) in group 1 and 7 patients (58%) in group 2 (p=0,05) and, of these, six patients (50%) needed a new surgical debridement. No severe side effects were reported in group 1 and only in 1 patient (8%) perilesional maceration was observed. In standard therapy frequency of dressing was twice a week and in gROS once a week, reducing costs related to nursing time and hospital visits, responsible of 80-85% of the total cost. Conclusion: Oleic matrix -- based gel releasing Reactive Oxygen Species promising to be effective, safe and efficient in tunnelling post-surgical dehiscence in diabetic foot. [ABSTRACT FROM AUTHOR]

Pure red cell aplasia (PRCA) may develop in patients with chronic kidney disease receiving erythropoiesis-stimulating agents (ESA). We report on a 72-year-old patient who developed hypo-proliferative anaemia unresponsive to ESA following the administration of epoetin zeta subcutaneously for 7 months. On the basis of severe isolated hypoplasia of the erythroid line in the bone marrow and high-titre neutralizing anti-erythropoietin antibodies (Ab), a diagnosis of Ab-mediated PRCA was made. Epoetin zeta was discontinued and the patient was given steroids. This was associated with anaemia recovery. To our knowledge this is the first PRCA case related to epoetin zeta. [ABSTRACT FROM AUTHOR]

Background: A pharmacoeconomic analysis of the RISCAVID database aimed at assessing the cost effectiveness of phosphate binders in preventing CV mortality and morbidity over 7 years was performed. Methods: Morbid or fatal events occurring in 750 chronic HD patients were recorded. Statistical analysis evaluated the distribution of variables and the effect of sevelamer on survival. A cost-effectiveness evaluation was performed using a probabilistic model based on a Markov chain. Results: Multivariate analysis showed that treatment with sevelamer was associated with a reduced stroke incidence by 52% (p = 0.04) and reduced levels of C-reactive protein (p < 0.01). Cost-effectiveness evaluation evidenced a 33% decrease in hospital-days for patients treated with sevelamer, with and without comorbidities compared to patients undergoing calcium binders treatment. Conclusion: Treatment withsevelamer was associated with a reduced risk of stroke in HD patients, with a clear saving on disease-related costs for the Italian National Healthcare System. © 2015 S. Karger AG, Basel [ABSTRACT FROM AUTHOR]

Background: Mediterranean-style diet has been considered for its important beneficial effects on the progression of CV disease. Wine is an important component of the Mediterranean diet, and moderate wine drinkers have lower mortality rates than nondrinkers and heavy drinkers in epidemiologic studies. The beneficial effects of red wine are thought to be dependent on the polyphenol compounds such as resveratrol that exhibit potent antioxidant activity. However, white wine, although lacking polyphenols, contains simple phenols, such as tyrosol (Tyr) and hydroxytyrosol (OH-Tyr), characteristic also of extra-virgin olive oil, which may share similar antioxidant and inflammatory properties. Patients and Methods: The effect of white wine and extra-virgin olive oil on inflammatory markers was evaluated in 10 healthy volunteers and in 10 patients with CKD (chronic kidney disease) K-DOQI stage III-IV in a prospective, single blind, randomized, cross-over trial. After two weeks of wash-out from alcoholic beverages, subjects were randomized to a cross-over design A-B or B-A of a 2-week treatment with white wine (4 ml/kg body weight, 0.48 g/kg of alcohol 12%, corresponding to 2-3 glasses/daily) and extra-virgin olive oil (treatment A) or extra-virgin olive oil alone (treatment B). The two study periods were separated by a two-week wash-out period. At baseline and at the end of each treatment, plasma levels of inflammatory markers C-reactive protein (CRP), interleukin-6 (IL-6), tumor necrosis factor-alpha (TNF-alpha), and interleukin-8 (IL-8) concentration were determined. Urinary levels of Tyr, OH-Tyr, and their metabolites were measured at the same time. Results: During combined consumption of white wine and extra-virgin olive oil (treatment A), plasma levels of CRP and IL-6 decreased from 4.1 ± 1.8 to 2.4 ± 1.9 mg/l (p < 0.05) and from 5.3 ± 3.2 to 3.4 ± 2.3 mg/l (p < 0.05) in CKD patients. CRP decreased from 2.6 ± 1.2 to 1.9 ± 0.9 mg/l (p < 0.05), and IL-6 decreased from 2.2 ± 1.8 to 1.7 ± 1.3 mg/l (p = ns) in healthy volunteers. No significant variation versus baseline was observed during treatment B. A significant increase in urinary Tyr and OH-Tyr was observed during treatment A (white wine and extra-virgin olive oil). Conclusions: Plasma markers of chronic inflammation were significantly reduced in CKD patients during the combined consumption of white wine and olive oil, suggesting a possible anti-inflammatory effect of this nutritional intervention. © 2015 S. Karger AG, Basel [ABSTRACT FROM AUTHOR]

Introduction: Several studies demonstrated that endothelium dependent vasodilatation is impaired in cardiovascular and chronic kidney diseases because of oxidant stress-induced nitric oxide availability reduction. The Mediterranean diet, which is characterized by food containing phenols, was correlated with a reduced incidence of cardiovascular diseases and delayed progression toward end stage chronic renal failure. Previous studies demonstrated that both red and white wine exert cardioprotective effects. In particular, wine contains Caffeic acid (CAF), an active component with known antioxidant activities. Aim of the study: The aim of the present study was to investigate the protective effect of low doses of CAF on oxidative stress-induced endothelial injury. Results: CAF increased basal as well as acetylcholine—induced NO release by a mechanism independent from eNOS expression and phosphorylation. In addition, low doses of CAF (100 nM and 1 μM) increased proliferation and angiogenesis and inhibited leukocyte adhesion and endothelial cell apoptosis induced by hypoxia or by the uremic toxins ADMA, p-cresyl sulfate and indoxyl sulfate. The biological effects exerted by CAF on endothelial cells may be at least in part ascribed to modulation of NO release and by decreased ROS production. In an experimental model of kidney ischemia-reperfusion injury in mice, CAF significantly decreased tubular cell apoptosis, intraluminal cast deposition and leukocyte infiltration. Conclusion: The results of the present study suggest that CAF, at very low dosages similar to those observed after moderate white wine consumption, may exert a protective effect on endothelial cell function by modulating NO release independently from eNOS expression and phosphorylation. CAF-induced NO modulation may limit cardiovascular and kidney disease progression associated with oxidative stress-mediated endothelial injury. [ABSTRACT FROM AUTHOR]

To evaluate the outcomes of a multidisciplinary team working on diabetic foot (DF) patients with critical limb ischemia (CLI) in a specialized center, the authors retrospectively traced all the patients admitted in their department in 3 consecutive years with a diagnosis of CLI. From January 2006 to December 2008, 245 consecutive DF patients with CLI according the TransAtlantic interSociety Consensus II criteria were included in the study. Treatment strategy was decided by a team of diabetologists, inteventional radiologists, and vascular surgeons. Technical and clinical success, mortality, and ulcer recurrence were evaluated at 6 months and at a mean follow-up of 19.5 ± 13.4 months. Percutaneous transluminal angioplasty (PTA) was performed in 189 (77%) patients, whereas medical treatment, open surgical revascularization (OSR), and primary amputation were performed in 44 (18.3%), 11 (4.3%), and 1 (0.5%) patients, respectively. Revascularization was successful in 227/233 (97.4%) patients. At follow-up, the overall clinical success rate was 60.4%; it was significantly (P = .001) higher after revascularization (75.9%) compared with medical treatment (48.3%). During follow-up, surgical interventions in the foot were 1.5 ± 0.4 in those treated with PTA, 1.6 ± 0.5 in those treated with OSR, and 0.3 ± 0.8 in those receiving medical therapy (P < .05 compared with the others). Ulcer recurrence occurred in 29 (11.8%) patients: 4 (1.6%) in PTA, 2 (0.8%) in OSR, and 23 (9.4%) in the medical therapy group (P < .05). Major amputation rate was 9.3%, being significantly (P = .04) lower after revascularization (5.2%) compared with medical therapy alone (13.8%). Cumulative mortality rate was 10.6%. In conclusion, this study confirms the positive role of a PTA-first approach for revascularizing the complex cases of DF with CLI in a teamwork management strategy. [ABSTRACT FROM PUBLISHER]

Cardiovascular disease is the leading cause of death in the general population; traditional risk factors seem inadequate to explain completely the remarkable prevalence of cardiovascular mortality and morbidity observed in the uremic population. A role for chronic inflammation has been well established in the development of atherosclerotic disease, and, on the basis of these observations, atherosclerosis might be considered an inflammatory disease. Inflammation has been implicated in the etiology of coronary artery disease in the general population, and traditional inflammatory biomarkers such as C-reactive protein (CRP) and interleukin-6 (IL-6) have been shown to predict cardiovascular events in both symptomatic and asymptomatic individuals as well as those in the uremic population. Later on, new nontraditional markers were related to the risk of cardiovascular morbidity and mortality in general and in uremic population. As a consequence of the expanding research base and availability of assays, the number of inflammatory marker tests ordered by clinicians for cardiovascular disease (CVD) risk prediction has grown rapidly and several commercial assays have become available. So, up to now we can consider that several new nontraditional markers as CD40-CD40 ligand system and pentraxin-3 seem to be significant features of cardiovascular disease in general and in ESRD population. [ABSTRACT FROM AUTHOR]

A 72-year-old male was referred to our hospital for a plantar ulceration that had occurred many years earlier. The lesion, with exuberant granulation and large areas of necrosis and fibrin, had long been treated by plastic surgeons with no positive evolution. At admission in our hospital no ischemia was detected, and foot radiograph was negative for bone involvement. The patient underwent a foot magnetic resonance imaging, which showed high vascularization in the plantar region and early capture of the contrast medium. We then performed multiple biopsies of the ulceration that revealed a moderately differentiated squamous cell carcinoma. The total body computed tomography exam raised a systemic involvement. A lymph node biopsy and immunohistochemistry assay on the pleural cytological sample proved the presence of a primary squamous cell carcinoma of the foot with systemic dissemination. Although rare, squamous cell carcinoma could be associated with chronic nonhealing ulcers; therefore, when a lesion does not heal, despite adequate standard treatment, its etiopathogenesis should be challenged. [ABSTRACT FROM AUTHOR]

Peripheral blood mononuclear cells (PBMNCs) are reported to prevent major amputation and healing in no-option critical limb ischemia (NO-CLI). The aim of this study is to evaluate PBMNC treatment in comparison to standard treatment in NO-CLI patients with diabetic foot ulcers (DFUs). The study included 76 NO-CLI patients admitted to our centers because of CLI with DFUs. All patients were treated with the same standard care (control group), but 38 patients were also treated with autologous PBMNC implants. Major amputations, overall mortality, and number of healed patients were evaluated as the primary endpoint. Only 4 out 38 amputations (10.5%) were observed in the PBMNC group, while 15 out of 38 amputations (39.5%) were recorded in the control group (p = 0.0037). The Kaplan–Meier curves and the log-rank test results showed a significantly lower amputation rate in the PBMNCs group vs. the control group (p = 0.000). At two years follow-up, nearly 80% of the PBMNCs group was still alive vs. only 20% of the control group (p = 0.000). In the PBMNC group, 33 patients healed (86.6%) while only one patient healed in the control group (p = 0.000). PBMNCs showed a positive clinical outcome at two years follow-up in patients with DFUs and NO-CLI, significantly reducing the amputation rate and improving survival and wound healing. According to our study results, intramuscular and peri-lesional injection of autologous PBMNCs could prevent amputations in NO-CLI diabetic patients. [ABSTRACT FROM AUTHOR]

Abstract: Aims: To investigate the effect of combined treatment with angiotensin-converting enzyme inhibitors (ACE) and statins on mortality in diabetic patients with critical limb ischemia (CLI). Methods: Prospective observational study of 553 consecutive diabetic patients admitted because of CLI followed for a mean of 2.2 years. All patients underwent peripheral revascularization and antithrombotic therapy was prescribed or continued and therapy with statin and ACE was recorded. Mortality from any cause was assessed and Kaplan–Meier analyses were performed to compare the relationship between survival and recorded variables. Results: One hundred thirty-nine patients did not have therapy with statin or an ACE, 78 had therapy with statin without ACE, 164 had therapy with ACE without statin and 172 patients had therapy with both statin and ACE. One hundred thirty-six patients died, 45/139 with neither statin nor ACE, 40/164 with ACE only, 26/78 with statin only, and 25/172 with both statin and ACE. Multivariate analysis confirmed the independent role of age, history of stroke, renal insufficiency and dialysis. Combined treatment with ACE and statin appeared to have a protective role. Conclusions: In patients with diabetes and CLI mortality after two years is high. Life expectancy was better in patients receiving combined therapy with ACE and statin but not with therapy with only a statin or an ACE. [Copyright &y& Elsevier]

Paclitaxel-eluting devices (PED) reduce restenosis and target lesion revascularization (TLR) in femoropopliteal intervention. Recent data suggest a two-fold increased long-term mortality in patients treated with PED. The aim of our study is to evaluate if endovascular therapy (EVT) with PED increases mortality risk in patients with symptomatic lower limb peripheral artery disease (PAD) compared to non-eluting devices (NED). The study is a retrospective, single-center registry on patients undergoing EVT for PAD from January 2009 to June 2018. Propensity score analysis on logistic regression model for independent predictors of long-term mortality was used to match PED and NED patients. Mortality was assessed at 2, 5 and 7 years in the entired matched population and in a sub-group of patients ≤75 years. During the study period, 1294 patients, 718 NED and 576 PED, met the inclusion/exclusion criteria and entered in the study. Propensity score matching analysis identified 854 matched patients, 414 PED and 440 NED. The population was mainly characterized by diabetic patients with CLI (80%) and high prevalence of CAD (30%), heart failure (15%) and renal insufficiency (20%). Mean follow-up length was 58 ± 34 months, (median 52.5). Mortality was 18% in NED vs 12% in PED patients at two years (p = 0.01), 36% vs 30% at 5 years (p = 0.03) and 41% vs 39% at seven years (p = 0.2) respectively. In patients ≤75 years, mortality at 7-year was 28% in PED vs 36% in NED, p = 0.07. These results suggest a reduced mortality at 2 and 5 years with PED as compare to NED treatment in a real-world CLI scenario. At 7-year follow-up, the advantage was numerically evident only in patients ≤75 years. • Angioplasty of lower limb arteries is associated with a high incidence of restenosis. • Paclitaxel-eluting devices reduce restenosis and target lesion revascularization in lower limb ischemia. • Recent data are conflicting about long-term mortality in patients treated with PED. • In real world scenario paclitaxel-eluting devices reduce major limb adverse events and mortality at 2 and 5 years follow-up. [ABSTRACT FROM AUTHOR]

Purpose: Infection, which is one of the possible complications of diabetic foot ulcers (DFUs), makes the treatment of ulcers challenging because of its negative impact on healing processes and the high prevalence of multiresistant germs. This study is aimed at verifying the effect of a surgical CO 2 laser (which reduces the bacterial load and allows a more accurate debridement), as compared with the traditional lancets, on the healing rate of DFU., Methods: The present case-control retrospective analysis was performed on patients with chronic (>6 months) DFU with Texas grade >1, treated with 80 W surgical CO 2 laser (DEKA SmartXide2 C80, El.En. Group) and compared with a matched sample of patients with similar characteristics, who were treated with a traditional surgical approach. The debridement was performed trying to achieve the complete removal of nonviable tissues. The principal endpoint was the proportion of patients healed at 6 months. All analyses were carried out with SPSS 25.0. The study protocol was approved by the local ethical committee., Results: This study included 118 patients (59 cases and 59 controls). At 6 months, the proportion of healing patients was 35% and 18% in cases and controls, respectively ( P = .034). The corresponding figure at 1 year was 62% and 38% ( P = .009), whereas no difference was observed at 1, 2, and 3 months. No serious adverse event was observed., Conclusions: In this article, we show for the first time that CO 2 laser treatment, in comparison with traditional surgical approaches, can be associated with an increased healing rate in patients with DFU.

Objective: To perform an early economic evaluation of a system based on photodynamic advanced adjuvant therapy with photosensitizer RLP068/CI to facilitate the healing process of foot/leg skin lesions/ulcers with an excellent safety profile., Design: An early short-term (10 weeks) cost-effectiveness and a budget impact analysis (over 5 years) comparing photodynamic therapy with photosensitizer RLP068/CI based (PDT-RLP068) system added to Standard of Care (SoC) vs SoC alone., Setting: The Italian National Healthcare System perspective considering both the outpatient and the day-hospital regimen., Participants: Hypothetical patients with diabetic foot infection (DFI) grades I/IIB., Interventions: The PDT-RLP068 system as an add-on to Standard of Care (SoC) vs SoC alone as the first-line treatment for the management of DFIs., Main Outcomes: Days within which the clinical target was achieved and direct health costs for patients' management., Results: Additional costs generated by the use of the PDT-RLP068 system progressively decreased as time to reach the target induced by the novel system decreased. In the outpatient regimen, when time to reach clinical target decreased in the range 7-28 days, ICERs varied from about 1€ to 70€ for each additional day gained with clinical target achieved. The system was dominant when halving time to reach the target in the outpatient regimen and even for modest reduction of time in day-hospital regimen. In terms of budget impact, when considering day-hospital regimen, if the PDT-RLP068 based system allowed a shortened duration to reach the clinical target of between 7-28 days, BI was 8,100,000€ to 700,000€, with saving less than 2,000,000€ with 50% reduction of time. Considering the inpatient setting, the use of the PDT-RLP068 system would result in saving even with the modest impact on the time needed to activate the healing process., Conclusion: The early economic evaluation performed suggested that, if the claimed effectiveness of the technology demonstrated in case reports and in preliminary clinical studies can be confirmed in larger population studies, and allowing for shortening of the time needed to activate the healing process, the PDT-RLP068 system could offer the chance to improve care for DFI patients without compromising the sustainability of the system., Competing Interests: Dr Valentina Lorenzoni and Professor Giuseppe Turchetti report grants from Molteni Farmaceutici SpA, during the conduct of the study. The authors report no other conflicts of interest in this work., (© 2021 Lorenzoni et al.)