Evaluating the Efficacy and Safety of NeoThelium FT Amnion Skin Graft in the Management of Venous Leg Ulcers: A Prospective Case Series
This is a prospective case series evaluating the efficacy and safety of NeoThelium FT Amnion Skin Graft in the Mangement of Venous Leg Ulcers
• Male or Female, 18 years of age or older
• Subject has a medical diagnosis of venous leg ulcer or venous insufficiency with a lower extremity wound
• Subject has an venous leg ulcer without infection or clinically visible exposed bone
• Index wound is a minimum of 1 cm2 and a maximum of 30 cm2 at first treatment visit
• 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.
• Venous Leg Ulcer is being treated with compression therapy for 7 days prior to treatment visit 1
• Index wound is free of necrotic debris prior to NeoThelium FT application
• Female subjects of childbearing potential having a negative pregnancy test prior to the first treatment visit
• Wound free of clinical signs/symptoms of infection (no purulent discharge or cellulitis) post-debridement during screening and prior to the first treatment visit.
⁃ Subject is able and willing to follow the protocol requirements
⁃ Subject had signed informed consent
⁃ If 2 or more wounds are present, the wounds must be separated by at least 2 cm