8-Week Study Comparing Berovenal and NU-GEL Hydrogel for Treating Chronic Diabetic Foot Ulcers in Adults Aged 18 to 85

What this Trial Is About

Researchers are evaluating the clinical efficacy and safety of the medical device Berovenal4, designed to promote healing of chronic diabetic foot ulcers in adults aged 18 to 85 years with type 1 or type 2 diabetes. The study compares Berovenal4 to a reference device with a similar purpose to determine if it can reduce ulcer size and improve healing outcomes. The investigation also monitors any medical problems participants may experience while using Berovenal4. Participants will use either Berovenal4, a light brown hydrogel in a tube, or the reference NU-GEL Hydrogel with Alginate, a transparent hydrogel in an ampoule, daily for up to 8 weeks or until their diabetic foot ulcer closes. The study is open-label and randomized, with clinic visits every 2 weeks for checkups and tests. Participants will keep a diary to record their symptoms and device usage throughout the treatment period. During the study, participants will undergo assessments of their ulcer size reduction, complete closure rates, time to closure, and quality of life using the Wound-QoL questionnaire at various intervals. Safety is monitored by tracking wound infections, adverse events, device failures, and complaints over the 8-week period. The main outcome is the percentage reduction in ulcer area after 8 weeks, with participants expected to attend regular clinic visits and maintain symptom diaries during their involvement.

The Purpose of This Study is to Assess Clinical Efficacy and Safety of Berovenal® Intended to Promote Treatment and to Expedite Chronic Diabetic Foot Ulcer Healing