RecruitingNot Applicable

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

Germany, Poland66 participantsStarted 2023-05-17

Plain-language 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

Who can participate

Age range

18 Years – 85 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 condition other than diabetes mellitus; * inadequate arterial circulation to the foot documented within 28 days prior to Visit 1, or during the screening period: * Ankle-brachial Index \< 0.7 or \> 1.3 and/or * Toe-brachial Index \< 0.7; * presence of acute Charcot's neuro-arthropathy, or osteomyelitis, on the affected foot within 3 months prior to Visit 1; * use of wound dressings that include growth factors, bioengineered tissues, or skin substitutes within 14 days prior to Visit 1, …

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Evaluation of clinical efficacy based on comparison of the percentage reduction in Index ulcer area.

Timeframe: 8 weeks

Trial details

NCT IDNCT06584617

SponsorVULM s.r.o.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-03

Contact for this trial

Marianna Forgáčová

+421 918 415 585 regulatory@vulm.sk

View on ClinicalTrials.gov More Diabetic Foot Ulcer trials