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