Non-healing Venous Leg Ulcers Treated With Standard Care With or Without BR-AC

Recruiting N/A Interventional Study
Non-infected Venous Leg Ulcer Venous Leg Ulcer Venous Insufficiency Venous Stasis Venous Reflux
No Placebo Group Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
18 and older
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
60 (estimated)
Sponsor
BioStem Technologies · Industry
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About This Trial
This study examines a patient population with a non-healing, non-infected venous leg ulcer (VLU) having adequate arterial perfusion with confirmed venous reflux. It is hypothesized that weekly applications of the human placental allograft BioREtain® Amnion Chorion (BR-AC) applied to a non-healing VLU will result in a higher proportion of wounds showing complete healing within 12 weeks of initiatin…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: 1. Patient has signed the informed consent form. 2. Male or female patient at least 18 years of age or older, as of the date of the screening visit. 3. Has a VLU between the knee and ankle (at or above the malleoli), with a surface area in the range of ≥ 2.0 cm2 and ≤ 20.0 cm2 w…
Contacts

Nick McCoy

2144571996

nmccoy@biostemtech.com

CONTACT