NuScience Medical Biologics, LLC
This is a prospective case series evaluating the efficacy and safety of NeoThelium FT Amnion Skin Graft in the Mangement of Venous Leg Ulcers
This research will take place across multiple medical centers, where both researchers and participants will know which treatment is being used (open label). Patients who agree to participate and meet the study requirements during screening will begin SOC plus NeoThelium FT weekly applications. The subject will continue follow-up per the original schedule. As this is a post-marketing study, it will gather information regarding the efficacy of treatment while also supporting insurance reimbursement decisions.
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 steno…
NeoThelium FT is a dehydrated wound covering derived from donated human placental tissue.
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