A Prospective, Post-market Randomized Controlled Trial (RCT) to Demonstrate Clinical Utility of an Amniotic Membrane Allograft in Diabetic Foot Ulcer (DFU) Wound Management
Legacy Medical Consultants
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.
Description
Lower extremity diabetic ulcers are a common complication affecting millions of people in the United States. The purpose of this study is to evaluate the clinical utility of Orion™, a dual-layer amniotic membrane allograft, versus standard wound care in the management of diabetic foot ulcers. Amniotic membrane allografts are confirmed by the FDA Tissue Reference Group to meet the criteria for regulation solely under Section 361 of the PHS Act as defined in 21 CFR Part 1271 for the management of diabetic foot ulcers. Investigators hypothesize that the group of participants who receive amniotic…
Eligibility
- Age range
- 50–85 years
- Sex
- All
- Healthy volunteers
- No
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…
Interventions
- DeviceOrion TM Amniotic Membrane Allograft
The intervention is a sterile allograft made from dehydrated extracellular matrix, designed to promote wound healing by providing a reliable and protective wound covering. Amniotic membranes are hypothesized to promote healing in open wounds by serving as a scaffold to support native tissue ingrowth, encouraging angiogenesis, and limiting microbial spread.
- ProcedureStandard of Care (SOC)
Standard wound care entails surgical debridement as needed to remove all non-viable tissue, screening for infection and probing of the wound for bone, weekly application of a collagen alginate primary dressing, and off-loading using a removable diabetic offloading cam-walker or total contact cast.
Locations (2)
- Center for Clinical Research Inc.San Francisco, California
- ILD Research CenterVista, California