Clinical Utility of an Amniotic Membrane Allograft for Diabetic Foot Ulcer Wound Management

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.

NCT Number	NCT06420245
Lead Sponsor	Legacy Medical Consultants
Conditions	Diabetic Foot Ulcer
Enrollment	240 participants
Start Date	2025-12-30
Primary Completion	2026-11 (estimated)
Study Completion	2027-07 (estimated)
Updated on ClinicalTrials.gov	2026-06-05