Prospective Case Series Evaluating the Efficacy and Safety of NeoThelium FT for Venous Leg Ulcers
Trial Parameters
Brief Summary
This is a prospective case series evaluating the efficacy and safety of NeoThelium FT Amnion Skin Graft in the Mangement of Venous Leg Ulcers
Eligibility Criteria
Inclusion Criteria: 1. Male or Female, 18 years of age or older 2. Subject has a medical diagnosis of venous leg ulcer or venous insufficiency with a lower extremity wound 3. Subject has an venous leg ulcer without infection or clinically visible exposed bone 4. Index wound is a minimum of 1 cm2 and a maximum of 30 cm2 at first treatment visit 5. Adequate circulation if wound is location on the lower extremity demonstrated by an ABI of \>0.7 and \<1.3, or TBI of \>0.6 within 30 days prior to informed consent OR an arterial ultrasound noted with patent circulation and without significant stenosis 90 days prior to the first treatment visit. 6. Venous Leg Ulcer is being treated with compression therapy for 7 days prior to treatment visit 1 7. Index wound is free of necrotic debris prior to NeoThelium FT application 8. Female subjects of childbearing potential having a negative pregnancy test prior to the first treatment visit 9. Wound free of clinical signs/symptoms of infection (no purul