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;
Parallel
Orion TM Amniotic Membrane Allograft
DeviceThe 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)
Procedure/SurgeryStandard 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.
Incidence of Complete Wound Closure
Percentage of enrolled study participants demonstrating 100% re-epithelialization of the index wound without leaking exudate at 12 weeks post-randomization.
Time to complete wound closure
time to 100% re-epithelialization of the index ulcer without leaking exudate as assessed by Kare inSight®, starting at randomization through identification of complete wound closure.
Incidence of complete wound closure
Incidence of complete wound closure, defined as 100% re-epithelialization of the index ulcer without leaking exudate as assessed by eKare inSight® at eight (8) weeks post-randomization.
Number of Orion™ Allografts or collagen alginate (SOC) dressings required for complete wound closure.
The number of Number of Orion™ Allografts or collagen alginate (SOC) dressings required for complete wound closure during twelve (12) week Wound Management Period.
Change in Quality of Life metrics
Change in QoL metrics at twelve (12) weeks post-randomization compared to baseline as reported by the subject in the WOUND-Q QoL questionnaires: Life Impact (8-32; higher is better); Lower Limb Symptoms (10-40; higher is better)
Per-Patient Product Cost
Per-patient product cost for Orion™ Allografts during the course of wound management.
Number of wound management products used.
Number of wound management products used in each group.
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