240
Participants
Start Date
October 31, 2025
Primary Completion Date
November 30, 2025
Study Completion Date
April 30, 2026
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.
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.
Lead Sponsor
Legacy Medical Consultants
INDUSTRY