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.
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…
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