Prospective Case Series Evaluating the Efficacy and Safety of NeoThelium FT for Chronic Pressure 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 Chronic Pressure Ulcers
Eligibility Criteria
Inclusion Criteria: 1. Male or Female, 18 years of age or older 2. Subject has a medical diagnosis of Pressure Injury/Ulcer located on the pelvis or lower extremity 3. Subject has a Pressure Injury/Ulcer Stage 2 or 3 without infection 4. Index ulcer is a minimum of 1cm2 and a maximum of 30cm2 at first treatment visit 5. Index ulcer has a depth of ≤ 1cm2, and subject is compliant to use continuous NPWT with 75-100mmHg, at the providers discretion 6. Index ulcer has a depth of \> 1cm2, and subject is compliant to use continuous NPWT with 75-100mmHg 7. Pressure Injury/Ulcer is treated with offloading therapy while standing, sitting and lying down (if applicable to wound location) for 7 days prior to the first treatment visit 8. Adequate circulation of ulcer, if located on the lower extremity, demonstrated by an ABI of \>0.7 and \<1.3, or TBI of \>0.6 within 30 days prior to the first treatment visit 9. Index ulcer is free of infection prior to the first treatment visit and during screenin