TLC-Ag dressings: a prospective, multicentre study on 728 patients with wounds at risk of or with local infection.

OBJECTIVE: This study aimed to evaluate the management of an unselected cohort of patients with wounds at risk of or with clinical signs of local infection, treated with two antimicrobial contact layers impregnated with silver (TLC-Ag healing matrix), under real-life conditions during the COVID-19 pandemic. METHOD: A large, prospective, multicentre, observational study with two TLC-Ag dressings (UrgoTul Ag/Silver and UrgoTul Ag Lite Border, Laboratoires Urgo, France) was conducted in Germany between May 2020 and May 2021. The main outcomes included a description of the treated patients and their wound management, the changes in wound infection and wound healing outcomes over a maximum period of four weeks of treatment, as well as the overall clinical assessment of the performance, local tolerance and acceptability of dressings. RESULTS: A total of 728 patients with wounds of various aetiologies and wound infection status were treated with the evaluated dressings in 39 centres for a mean duration of 26±19 days, with an intermediate visit conducted in 712 (97.8%) patients after a mean period of 12±9 days. At the initial visit, it was established that the majority of patients (60.4%) had a wound infection, while the remaining cohort presented first clinical signs of a local wound infection (25.1%) or were at risk of wound infection (13.2%) (unclear status in 1.2%). Throughout the study period, all the parameters of wound infection continuously decreased, resulting at the final visit in a reduction by 78.9% of the prevalence of local wound infections and by 72.0% of the clinical signs of wound infection, the most rapidly diminished clinical sign being wound deterioration. Concurrently, in terms of the healing process, 92.1% of the wounds healed or improved, 3.2% remained unchanged and 1.7% worsened (data missing for 3.0%), and an improvement of the periwound skin was reported in 65.7% of the patients. Overall, the two dressings were 'very well accepted' by the majority of patients, with no uncomfortable feeling at wearing and no pain at dressing removal, and were assessed by the physicians as 'very useful' in the majority of the cases with a 'very good' efficacy in terms of antimicrobial activity and promotion of the wound healing process. Similar results were reported regardless of the wound type treated or of the TLC-Ag dressing evaluated. CONCLUSION: These results are consistent with previous clinical evidence on TLC-Ag dressings. They support the good efficacy, good tolerability and usefulness of these antimicrobial dressings in the management of patients with wounds at risk or with clinical signs of local infection, in association with appropriate standard of care.

Impact of wound duration on diabetic foot ulcer healing: evaluation of a new sucrose octasulfate wound dressing.

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.

Diabetic foot syndrome in patients with diabetes. A multicenter German/Austrian DPV analysis on 33 870 patients.

AIMS: The diabetic foot syndrome (DFS) is a serious complication in patients with diabetes increasing the risk for minor/major amputations. This analysis aimed to examine differences in diabetes patients with or without DFS stratified by type 1 (T1D) or type 2 diabetes (T2D). MATERIAL AND METHODS: Adult patients (≥20y of age) with diabetes from the German/Austrian diabetes patients follow-up registry (DPV) were included. The cross-sectional study comprised 45 722 subjects with T1D (nDFS  = 2966) and 313 264 with T2D (nDFS  = 30 904). In DFS, minor/major amputations were analysed. To compare HbA1C , neuropathy, nephropathy, cardiovascular disease risk factors, and macrovascular complications between patients with or without DFS, regression models were conducted. Confounders: age, sex, diabetes duration. RESULTS: In patients with DFS, a minor amputation was documented in 27.2% (T1D) and 25.9% (T2D), a major amputation in 10.2% (T1D) and 11.3% (T2D). Regression models revealed that neuropathy was more frequent in subjects with DFS compared with patients without DFS (T1D: 70.7 vs 29.8%; T2D: 59.4% vs 36.9%; both P < 0.0001). Hypertension, nephropathy, peripheral vascular disease, stroke, or myocardial infarction was more common compared with patients without DFS (all P < 0.0001). In T1D with DFS, a slightly higher HbA1C (8.11% vs 7.95%; P < 0.0001) and in T2D with DFS a lower HbA1C (7.49% vs 7.69%; P < 0.0001) was observed. CONCLUSIONS: One third of the patients with DFS had an amputation of the lower extremity. Especially neuropathy or peripheral vascular disease was more prevalent in patients with DFS. New concepts to prevent DFS-induced amputations and to reduce cardiovascular risk factors before the occurrence of DFS are necessary.

Female sex, young age, northern German residence, hypoglycemia and disabling diabetes complications are associated with depressed mood in the WHO-5 questionnaire - A multicenter DPV study among 17,563 adult patients with type 2 diabetes.

BACKGROUND: Like other mental illnesses, depression is a culturally sensitive topic. Hence, findings cannot be transferred between countries. We investigated the frequency of depressed mood and its association with diabetes-related factors in a large type 2 diabetes (T2D) cohort from real-life care in Germany. METHODS: 17,563 adults (median [IQR]: 64.5[55.9-71.1] years) from the multicenter diabetes follow-up registry, DPV (diabetes prospective follow-up), were investigated. All had completed the WHO-5 questionnaire, a screening tool for depression. Logistic regression was applied to study the association of demographic and diabetes-related factors with depressed mood (SAS 9.4). P<0.05 was considered significant. RESULTS: Using a WHO-5 cut-off of <13, 27.4% of patients were at risk for depressed mood. A clinical depression diagnosis was recognized in 8.4%. Female sex (OR: 1.5[95%-CI: 1.4-1.6]), young age (1.2[1.1-1.4]), longer diabetes duration (1.2[1.1-1.3]), and living in Northern Germany (1.3[1.2-1.4]) were each associated with increased odds for depressed mood. After adjusting for these confounders, worse glycemic control (1.4[1.3-1.5]), insulin use (1.3[1.2-1.4]), myocardial infarction (1.3[1.2-1.5]), stroke (1.8[1.5-2.0]), retinopathy (1.4[1.3-1.6]), renal failure (1.4[1.2-1.8]), diabetic foot syndrome (1.3[1.2-1.4]), severe hypoglycemia (1.5[1.2-1.9]), two or more inpatient admissions (2.1[1.8-2.4]), and longer duration of hospital stay (1-<14 days: 1.3[1.2-2.3]; >14 days: 2.1[1.9-2.3]) were related to depressed mood. LIMITATION: Due to the cross-sectional design, no causality can be drawn. CONCLUSIONS: In T2D, depressed mood is not uncommon. However, in routine care a clinical depression might be missed and regular screening is advisable. Besides the well-known associations with depressed mood, northern German residence and mainly life-compromising diabetes comorbidities were identified as related factors.