Actively Recruiting
Clinical Utility of an Amniotic Membrane Allograft for Diabetic Foot Ulcer Wound Management
Led by Legacy Medical Consultants · Updated on 2026-02-02
240
Participants Needed
2
Research Sites
78 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Clinical Utility of an Amniotic Membrane Allograft for Diabetic Foot Ulcer Wound Management
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Ambulatory patients aged 50 to 85 years
- Able and willing to provide informed consent
- Willing and able to follow study requirements
- Have a Wagner 1 or superficial Wagner 2 diabetic foot ulcer on the foot below the ankle
- If multiple ulcers, the largest eligible ulcer will be used
- Ulcer can be visualized and measured with eKare Insights
- Other ulcers must be at least 2 cm away from the study ulcer
- Ulcer present for at least 4 weeks and less than 52 weeks before consent
- Ulcer size between 1.0 cm2 and 25 cm2 at screening and first visit
- Ulcer offloaded according to standard care before randomization
- Participant under care of a clinician for diabetes and other conditions
- Adequate blood flow in the foot demonstrated by specific tests within 30 days of screening
You will not qualify if you...
- Ulcer caused by a condition other than diabetes
- Having five or more diabetic foot or venous leg ulcers on the target limb
- Ulcer due to Charcot neuroarthropathy
- Use of antibiotic dressings within 4 weeks before screening
- Ulcer suspected or confirmed to be cancerous
- Ulcer site previously treated with radiation
- Presence of venous leg ulcers
- Active infection near or at the ulcer site
- Ulcer area reduced by 20% or more after 4-week run-in period
- Active bone infection within 30 days of first visit
- Raynaud's disease
- Severe arterial disease that cannot be fixed
- Use of immunosuppressive drugs or systemic corticosteroids for 2 weeks or more within 30 days before screening
- Active cancer treatment within 30 days before first study visit or planned during study
- Chemotherapy within 30 days before first visit or planned during study
- Poor diabetes control with HbA1c of 12% or higher within 30 days before first visit
- Participation in another investigational study currently or within 30 days before first visit
- Use of advanced skin substitute on the ulcer within 60 days before first visit
- Use of prohibited therapies on ulcer during study
- Use of COX-2 inhibitors such as celecoxib or others
- Serum creatinine above 2.5 mg/dL within 30 days before first visit
- Autoimmune connective tissue disease
- End stage renal disease
- Any condition compromising ability to complete study
- History of poor adherence to medical therapy or appointments
- Pregnant or planning pregnancy during study
- Life expectancy less than 1 year
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Center for Clinical Research Inc.
San Francisco, California, United States, 94115
Actively Recruiting
2
ILD Research Center
Vista, California, United States, 92081
Actively Recruiting
Research Team
C
Cyaandi Dove, DPM
CONTACT
C
Christopher Schultz, BS, CCRA, ACRP-PM
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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