Kosching

Researchers are investigating the clinical effectiveness 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 similar reference hydrogel device to see if it reduces the size of diabetic foot ulcers and to monitor any medical issues during use. Participants will apply either Berovenal4, a light brown, water-washable hydrogel, or the reference NU-GEL Hydrogel with Alginate daily for up to 8 weeks or until their foot ulcer heals. They will attend clinic visits every 2 weeks for checkups and tests, and keep a diary recording symptoms and device usage. The study is open-label and randomized, conducted across multiple centers. During the study, researchers will measure the reduction in the ulcer area over 8 weeks to assess clinical efficacy. Participants will be monitored through regular visits including tests and symptom diaries to evaluate safety and healing progress. The total study participation lasts 8 weeks, with ongoing assessment of device use and ulcer healing.