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.
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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

Marianna Forgáčová

+421 918 415 585

regulatory@vulm.sk

CONTACT

Juraj Keszegh

+421 904 967 555

juraj.keszegh@gmail.com

CONTACT