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
Trial Parameters
Brief 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
Eligibility Criteria
Inclusion Criteria: * male, or female subjects aged 18-85 years; * diabetes mellitus (type 1 or 2) documented at least 12 months prior to Visit 1; * presence of a diabetic foot ulcer meeting the following criteria (Index ulcer): * grade 1 or 2 according to the Wagner classification; * if applicable, surgically debrided ≥ 7 days prior to Visit 1; * at the time of randomisation: * sized 1 - 25 cm2; * present for ≥ 14 days; * offloaded for ≥ 7 days; * not infected. * HbA1c ≤ 10% (DCCT) or 85.8 mmol/mol (IFCC) at Visit 1; * willing and able to comply with the scheduled procedures; * legally capable, able to understand the provided information and willing to sign the informed consent form. Exclusion Criteria: * known contraindication for application of hydrogel dressings, incl. Berovenal® and NU-GEL Hydrogel with Alginate; * at the time of randomisation - documented reduction in Index ulcer area by \> 20%, as compared to its size at Visit 1; * Index ulcer primarily caused by a medical condi