NCT06584617

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

A Prospective, 8-week, Multi-centre, Randomised, Open-label Clinical Investigation Comparing Clinical Efficacy and Safety of Berovenal® with a Reference Amorphous Hydrogel in Subjects with Shallow, Non-infected, Chronic Diabetic Foot Ulcer

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 66 (estimated)
• Sponsor: VULM s.r.o. · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical investigation is to evaluate clinical efficacy of medical device Berovenal® intended to promote treatment and to expedite healing of chronic diabetic foot ulcer in male or female subjects aged 18-85 years with diabetes mellitus (type 1 or 2) and with present diabetic foot ulcer by providing moist environment similar to intracellular environment of the damaged tissue. It will also learn about the safety of medical device Berovenal®. The main questions it aims to answer are: * Does medical device Berovenal® lower the size of diabetic foot ulcer? * What medical problems do participants have when using medical device Berovenal®? Researchers will compare medical device Berovenal® to a reference device (device with similar purpose of use). Participants will: * Use medical device Berovenal® or a reference device every day for 8 weeks or to the time point when the diabetic foot is closed * Visit the clinic once every 2 weeks for checkups and tests * Keep a diary of their symptoms and the number of times they use medical device Berovenal® or a reference device

Conditions

• Diabetic Foot Ulcer

Interventions

Type	Name	Description
DEVICE	Berovenal®	Easy to spread, water-washable, light brown, turbid hydrogel in tube containing 30 g of hydrogel and closed with a plastic screw cap.
DEVICE	NU-GEL Hydrogel with Alginate	Transparent, easy to spread and water-washable hydrogel in ampoule (concertina pack) containing 25 g or 15 g of hydrogel and closed with a plastic cap.

Timeline

• Start date: 2023-05-17
• Primary completion: 2025-03-01
• Completion: 2025-12-01
• First posted: 2024-09-05
• Last updated: 2024-09-05

Locations

9 sites across 2 countries: Germany, Poland