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

NANot yet recruitingINTERVENTIONAL
Enrollment

240

Participants

Timeline

Start Date

October 31, 2025

Primary Completion Date

November 30, 2025

Study Completion Date

April 30, 2026

Conditions
Diabetic Foot Ulcer
Interventions
DEVICE

Orion 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.

PROCEDURE

Standard 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.

Sponsors
All Listed Sponsors
lead

Legacy Medical Consultants

INDUSTRY

NCT06420245 - Clinical Utility of an Amniotic Membrane Allograft for Diabetic Foot Ulcer Wound Management | Biotech Hunter | Biotech Hunter