Clinical Utility of an Amniotic Membrane Allograft for Diabetic Foot Ulcer Wound Management
Trial Parameters
Brief Summary
The goal of this clinical trial is to learn if use of Orion™, a dual-layer amniotic membrane allograft, in addition to standard wound care treatment can improve patient outcomes for people over the age of 50 with diabetic foot ulcers. The study aims to determine the incidence of complete wound closure at the end of 12 weeks of treatment. Researchers will compare the outcomes between a group of people treated with standard wound care and another group treated with standard wound care in addition to the amniotic membrane allograft to see if the amniotic membrane allograft improves wound healing. During the study, participants will visit their doctor weekly over a 12 week period, which is standard for diabetic foot ulcer treatment procedures, and fill out a questionnaire measuring quality of life.
Eligibility Criteria
Inclusion Criteria 1. Ambulatory patients ≥ 50 and ≤ 85 years of age; 2. Willing and able to provide informed consent; 3. Willing and able to comply with study requirements; 4. Presence of Wagner 1 and superficial Wagner 2 DFU extending at least through the dermis provided the DFU is located in the foot distal to the medial malleolus 5. If multiple Wagner 1 and superficial Wagner 2 DFUs are present, the largest ulcer meeting DFU eligibility criteria will be selected as the index DFU in the study; 6. Index ulcer is able to be visualized and accurately measured with eKare Insights; 7. Non-study ulcers must be \> 2 cm (.79 in.) from the index ulcer; 8. Index DFU identified ≥ 4 weeks prior to study screening and \< 52 weeks from the date of informed consent; 9. Index DFU area \> 1.0 cm2 (0.39 in.) and \< 25 cm2 (9.84 in.) at screening and at Wound Management Period Visit #1; 10. Index DFU offloaded according to SOC for entire run-in period, prior to randomization; 11. Potential participant