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
Recruiting
N/A
Interventional Study
Diabetic Foot Ulcer
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
At a Glance
- Age
- 18 – 85
- Sex
- Any
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 66 (estimated)
- Sponsor
- VULM s.r.o. · Industry
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About This Trial
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 w…
Trial Locations
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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 appli…
Contacts