Effectiveness of Diamelandreg; In the Treatment of Diabetic Foot Ulcers: A Randomized and Placebo-Controlled Phase II Clinical Trial

Abstract

Introduction: Diabetic foot ulcers are one of the most serious complications for patients with diabetes mellitus. The use of nutritional supplements such as Diamel® can be considered as an adjunct to conventional treatment in affected patients. Objective: To evaluate the effectiveness of the product Diamel® in the treatment of diabetic foot ulcers. Methods: Phase II double-blind, randomized, placebo-controlled clinical trial in a sample of 100 patients of both sexes with type 2 diabetes mellitus (DM) and with Wagner grade I-II-foot ulcers. All of them received conventional therapy, 50 of them combined with the product Diamel® and 50 combined with placebo. They followed up for a period of 1 year. The proportions of healed patients were taken as a response variable to determine efficacy. Other variables are analyzed: body mass index, glycemia, glycosylated hemoglobin, cholesterol, triglycerides, and creatinine, which were compared at the beginning and end of the study. Data analysis was performed according to the intention-to-treat principle. Results: The Diamel® group showed a 1-year cumulative healing rate of 89.2% (95% CI, 77.4-96.5) vs 72.4% (95% CI, 58.0-85.1) in the placebo group. The average healing time for ulcers in the Diamel® group was 3 months, significantly less than the Placebo group, which took 5 months, p=0.001. At the end of the study, HbA1c and fasting blood glucose had decreased significantly in the Diamel® group. Recurrence rates were lower in the Diamel® group (3 patients, 8%) than in the placebo group (8 patients, 16%), and no major adverse effects were reported in relation to the supplement. Conclusions: The Diamel® nutritional supplement showed a sufficient degree of efficacy in the treatment of diabetic foot ulcers in patients with type 2 DM, so large-scale studies should be undertaken.