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.
Ambulatory patients ≥ 50 and ≤ 85 years of age;
Willing and able to provide informed consent;
Willing and able to comply with study requirements;
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
Index foot ulcer documented to be caused by a medical condition other than diabetes;
Potential subject has five (5) or more DFUs and/or VLUs in the target limb;
DFU is secondary to Charcot neuroarthropathy;
Treatment with an antibiotic impregnated primary dressing ≤ 4 weeks prior to study screening;