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Aims: This study aimed to evaluate the performances of lipid colloid technology with nano-oligosaccharide factor (TLC-NOSF) dressings with polyabsorbent fibres in an unselected population of patients under real-life conditions. Methods: A large, prospective, multicentre, observational study with three polyabsorbent TLC-NOSF dressings (UrgoStart Plus Pad, UrgoStart Plus and UrgoStart Plus Border, Laboratoires Urgo, France) was conducted in Germany between January 2019 and June 2020. Main outcomes included wound healing rate, clinical assessment of wound healing progression, local tolerance and acceptance of dressings, and changes in health-related quality of life (HRQoL) of the patients, assessed with the validated Wound-QoL questionnaire. Results: A total of 961 patients with wounds of various aetiologies (leg ulcers (LU), diabetic foot ulcers (DFU), pressure ulcers (PU) and other types of wounds) were treated with the evaluated dressings in 105 centres for a mean duration of 62 days (standard deviation 37 days). By the last visit, a wound closure or an improvement in wound healing was reported in 92.0% of the treated wounds. The highest wound closure rates were achieved when the dressings were used as first-line treatment: 71.3% in DFUs, 52.9% in LUs, 53.6% in PUs and 61.8% in the other wounds. Improvement of the wound healing process was also associated with an 87.5% relative reduction of sloughy tissue, a decrease of the level of exudate in 68.9% of the wounds, and an improvement in the periwound skin condition in 66.4% of the patients at the final visit. The dressings were 'very well' or 'well' tolerated and 'very well' or 'well' accepted by the large majority of patients. The HRQoL questionnaires were completed both at initial and final visits by 337 patients, representative of the total cohort. Despite the relatively short duration of the wounds, the HRQoL of the patients was already impaired at baseline, with 81.6% of the patients being severely affected in at least one aspect of their HRQoL. By the final visit, significant improvements in each dimension of the patients' HRQoL were reported (p<0.001), along with a reduction of the proportion of patients in need of intervention and in the number of actions needed per patient in relation to their HRQoL. Conclusions: These results are consistent with previous clinical evidence on TLC-NOSF dressings. They confirm the good healing properties and safety profile of these dressings, and that a significant improvement in patient HRQoL is achieved in non-selected patients treated in real-life practice. These data support the use of such dressings as a first-line intervention and until wound healing in the management of chronic wounds, in association with appropriate standard of care. [ABSTRACT FROM AUTHOR]

Objective: A common and frequent complication of diabetes is diabetic foot ulcers (DFU), which can have high treatment costs and severe adverse events. This study aims to evaluate the effects of wound duration on wound healing and the impact on costs, including treatment with a new sucrose octasulfate dressing compared with a control dressing. Method: Based on the Explorer study (a two-armed randomised double-blind clinical trial), a cost-effectiveness analysis compared four different patient groups distinguished by their wound duration and additionally two DFU treatment options: a sucrose octasulfate dressing and a neutral dressing (as control). Clinical outcomes and total direct costs of wound dressings were evaluated over 20 weeks from the perspective of the Social Health Insurance in Germany. Simulation of long-term outcomes and costs were demonstrated by a five cycle Markov model. Results: The results show total wound healing rates between 71% and 14.8%, and direct treatment costs for DFU in the range of €2482–3278 (sucrose octasulfate dressing) and €2768–3194 (control dressing). Patients with a wound duration of ≤2 months revealed the highest wound healing rates for both the sucrose octasulfate dressing and control dressing (71% and 41%, respectively) and had the lowest direct treatment costs of €2482 and €2768, respectively. The 100-week Markov model amplified the results. Patients with ≤2 months' wound duration achieved wound healing rates of 98% and 88%, respectively and costs of €3450 and €6054, respectively (CE=€3520, €6864). Sensitivity analysis revealed that the dressing changes per week were the most significant uncertainty factor. Conclusion: Based on the findings of this study, early treatment of DFU with a sucrose octasulfate dressing is recommended from a health economic view due to lower treatment costs, greater cost-effectiveness and higher wound healing rates. [ABSTRACT FROM AUTHOR]

Abstract: Wound healing in diabetes is impaired, and nonhealing ulceration represent clinically relevant complications. Persistently high levels of matrix metalloproteases (MMPs) contribute to wound chronicity. Thus, the topical use of protease inhibitors might influence wound healing and promote transition from a chronic to an acute wound. Methods: In this study, 33 patients with chronic diabetic foot lesions (stage 2a of the University of Texas Wound Classification system) were included. Fifteen patients received redundant “good standard wound care.” In addition, 18 patients were treated with a protease inhibitory modulating matrix (the OCR/collagen Promogran matrix, Ethicon) with dressings changed on a daily basis. Prior to treatment and at 4 and 8 days after treatment, two 3-mm punch biopsies were taken from the center of the wounds and analyzed using ELISA techniques for MMPs, tissue inhibitor of MMP-2 (TIMP-2), and interleukin-1β (IL-1β) levels. In addition, mRNA levels of MMPs as well as IL-1β and TNF-α were detected using quantitative real-time polymerase chain reaction (TaqMan, Applied Biosystems, Weiterstadt, Germany). Results: No differences were detected between both groups and at the three time points for the mRNA levels of MMPs as well as of IL-1β and TNF-α. In addition, MMP levels in wound tissue (analyzed by ELISA) were also not significantly different between both groups. However, IL-1β was increased on day 8 in the treatment group (P=.01) only. Interestingly, we found a significant reduction of the MMP-9/TIMP-2 ratio in the group being treated with the ORC/collagen. These wounds exhibited a more rapid healing rate when treated with the ORC/collagen matrix. Conclusions: The local treatment with a protease inhibitor has a beneficial effect on wound healing. In contrast to the data on wound fluid, our study demonstrated for the first time the unaltered mRNA levels of MMPs during treatment with a protease inhibitory modulating matrix. At the cellular level, MMPs were also not statistically different. However, the more relevant ratio of MMP-9/TIMP-2 was decreased in the treatment group. An equally important finding was that we did not detect a compensatory increase in the MMP-RNA expression even though wound size was clearly reduced. [Copyright &y& Elsevier]

Analyzes the cellular and molecular abnormalities contributing to diabetic foot syndrome. Discussion on the phases of wound healing; Details of the pathogenesis of wound healing in chronic wounds; Information on clinical studies with growth factors and protease inhibitors.

Objective: Pupillary autonomic neuropathy is considered an early sign of the development of systemic autonomic neuropathy. Sympathetic denervation is related to the duration of diabetes and the development of systemic autonomic dysfunction. We investigated pupil responsiveness to directly and indirectly acting sympathomimetics in type 1 diabetic patients with and without long-term complications, defined as cardiac autonomic neuropathy (CAN), peripheral sensomotor neuropathy, retinopathy, and nephropathy, and in healthy subjects.Research Design and Methods: A total of 47 randomly chosen type 1 diabetic patients and 20 healthy subjects were selected for this study. Patients were divided into groups determined by whether they had long-term diabetic complications. Pharmacological tests were performed with cocaine 4%, epinephrine 1%, and pholedrine 5% eye drops. Horizontal pupil diameter (HPD) was measured at the beginning of the pharmacological tests and at defined time points after instillation of the eye drops.Results: Statistical analysis showed a significantly smaller HPD in the patients before instillating eye drops (P = 0.011). In particular, the HPD was significantly smaller in the patient group without CAN when compared with healthy subjects (P = 0.004). Maximal cocaine reaction was diminished in the complication group (P < 0.001). Epinephrine test, visual acuity, ocular pressure, and HbA(1c) did not differ in patients with or without long-term complications. The noncomplication group showed no significant differences in pupillary responses as compared with healthy subjects. The complication group showed a smaller HPD (P = 0.022), reduced pupillary responses in the cocaine (P = 0.037) and pholedrine tests (P < 0.001), and anisocor pupil sizes after instillation of the eye drops (P = 0.034).Conclusions: Our results clearly show that sympathetic denervation does exist in the pupil of diabetic patients and that it can be rapidly assessed using the cocaine test. These data and the results of the epinephrine test suggest a mixed pre- and postganglionic dysfunction of the sympathetic plexus. The significant smaller HPD in patients without CAN compared with that of healthy subjects could be a sign for early involvement of the pupil function before cardiac manifestation of systemic autonomic diabetic neuropathy. [ABSTRACT FROM AUTHOR]

Objective: Dyslipidemia in patients with type 2 diabetes is characterized by elevated triglyceride levels, decreased high-density lipoprotein (HDL) cholesterol, and a predominance of small dense low-density lipoprotein (LDL) particles. Also, patients suffer from β-cell dysfunction, chronic systemic inflammation, increased hormonal visceral adipose tissue activity, and an increased risk of cardiovascular events. The aim of our study was to investigate the effect of a fixed pioglitazone + metformin (PM) combination (vs. glimepiride + metformin [GM]) on diabetic dyslipidemia. Research Design and Methods: A total of 288 type 2 diabetes patients completed this double-blind parallel study (187 men, 101 women; age [mean ± SD], 59 ± 10 years; body mass index, 32.6 ± 5.1 kg/m2; hemoglobin A1c [HbA1c], 7.3 ± 0.8%). They were randomized to PM or GM for 6 months. Observation parameters at baseline and end point included HDL, LDL, triglycerides, fasting insulin, fasting glucose, total adiponectin, intact proinsulin, and high-sensitivity C-reactive peptide (hsCRP). Results: HDL increased in the PM group by 0.08 ± 0.25 mmol/L (GM, −0.01 ± 0.2.8 mmol/L; P < 0.001 vs. PM), whereas LDL increased in both groups (GM, 0.25 ± 0.90 mmol/L; PM, 0.29 ± 0.66 mmol/L; difference not significant between groups). Improvements were seen for triglycerides (PM, −0.47 ± 1.30; GM, −0.19 ± 1.39 mmol/L), HbA1c (PM, −0.8 ± 0.9%; GM, −1.0 ± 0.9%), and glucose (PM, −1.2 ± 2.1; GM, −1.2 ± 2.2 mmol/L). Decreases in fasting insulin (PM, −5.2 ± 11.9; GM, −0.1 ± 9.8 μU/mL; P < 0.001 between groups), hsCRP (PM, −0.9 ± 1.9; GM, 0.0 ± 1.8 mg/L; P < 0.001), and fasting intact proinsulin (PM, −5.5 ± 11.1; GM, −0.1 ± 10.0 pmol/L; P < 0.001) and an increase in adiponectin (PM, +6.8 ± 6.4 mg/L; GM, +0.7 ± 2.7 mg/L; P < 0.001) were seen in the PM arm, only. Conclusions: With comparable glycemic control, the fixed PM combination was more efficacious on HDL cholesterol improvement than the GM combination. Additional positive effects were observed for biomarkers of lipid metabolism, β-cell function, activity of the visceral adipose tissue, and chronic systemic inflammation. [ABSTRACT FROM AUTHOR]