Orion™ amniotic membrane patch for diabetic foot ulcers

A Prospective, Post-market Randomized Controlled Trial (RCT) to Demonstrate Clinical Utility of an Amniotic Membrane Allograft in Diabetic Foot Ulcer (DFU) Wound Management

This study will test whether adding Orion™, a dual-layer amniotic membrane allograft, to standard wound care helps people aged 50–85 heal diabetic foot ulcers faster and achieve full closure within 12 weeks.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 240 (estimated)
• Ages: 50 Years to 85 Years
• Sex: All
• Sponsor: Legacy Medical Consultants (industry)
• Drugs / interventions: chemotherapy, radiation
• Locations: 2 sites (San Francisco, California and 1 other locations)
• Trial ID: NCT06420245 on ClinicalTrials.gov

What this trial studies

This interventional study randomizes ambulatory adults with Wagner 1 or superficial Wagner 2 diabetic foot ulcers to receive either standard wound care alone or standard care plus the Orion™ dual-layer amniotic membrane allograft. Participants visit the clinic weekly for 12 weeks for wound measurement with digital imaging (eKare Insights) and to receive offloading and standard care, while quality-of-life questionnaires are collected. The primary outcome is the incidence of complete wound closure at 12 weeks, with secondary analyses of wound-size reduction and quality-of-life changes. The product is regulated under FDA Section 361 as an amniotic tissue allograft.

Who should consider this trial

Good fit: Ambulatory adults aged 50–85 with a single Wagner 1 or superficial Wagner 2 foot ulcer between 1.0 and 25 cm² that has been present 4–52 weeks and can be offloaded and measured with eKare are ideal candidates.

Not a fit: People with deeper (beyond superficial Wagner 2), infected or ischemic ulcers, non-ambulatory patients, or ulcers outside the specified size or duration ranges are unlikely to receive benefit from this protocol.

Why it matters

Potential benefit: If successful, adding the amniotic membrane allograft could increase the rate of complete wound closure and shorten healing time, potentially lowering risks of infection and amputation.

How similar studies have performed: Previous studies of various amniotic membrane products have shown improved healing rates for chronic wounds including some diabetic foot ulcers, though results vary by product and study quality.

Eligibility criteria

Inclusion Criteria

1. Ambulatory patients ≥ 50 and ≤ 85 years of age;
2. Willing and able to provide informed consent;
3. Willing and able to comply with study requirements;
4. 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
5. If multiple Wagner 1 and superficial Wagner 2 DFUs are present, the largest ulcer meeting DFU eligibility criteria will be selected as the index DFU in the study;
6. Index ulcer is able to be visualized and accurately measured with eKare Insights;
7. Non-study ulcers must be \> 2 cm (.79 in.) from the index ulcer;
8. Index DFU identified ≥ 4 weeks prior to study screening and \< 52 weeks from the date of informed consent;
9. Index DFU area \> 1.0 cm2 (0.39 in.) and \< 25 cm2 (9.84 in.) at screening and at Wound Management Period Visit #1;
10. Index DFU offloaded according to SOC for entire run-in period, prior to randomization;
11. Potential participant is under the care of a clinician for diabetic management and other medical conditions (the site PI may assist/direct the patient in the pre-screening period to obtain a PCP).
12. Index foot has adequate circulation defined as meeting one (1) of the following within 30 days of screening:

A. ABI ≥ 0.7 and ≤ 1.3 AND TBI \> 0.7; B. Dorsum transcutaneous oxygen tension measurement (TcPO2) ≥ 40 mmHg; C. Arterial duplex with biphasic flow in BOTH the DP and PT arteries verified by PI and documented.

Exclusion Criteria

1. Index foot ulcer documented to be caused by a medical condition other than diabetes;
2. Potential subject has five (5) or more DFUs and/or VLUs in the target limb;
3. DFU is secondary to Charcot neuroarthropathy;
4. Treatment with an antibiotic impregnated primary dressing ≤ 4 weeks prior to study screening;
5. Index ulcer is potentially or confirmed by biopsy to be cancerous;
6. Index ulcer site has undergone radiation therapy;
7. Venous leg ulcers in diabetic patients;
8. Active infection proximal to or at site of index ulcer;
9. Index foot ulcer reduced in area by ≥ 20% at the end of the 4-week run-in period;
10. Presence of active osteomyelitis or bone infection as verified by x-ray /MRI within 30 days of visit #1 of the run-in period;
11. Raynaud's disease;
12. Unreconstructible arterial ischemia which may lead to nonhealing;
13. Treatment with immunosuppressants, including systemic corticosteroids for ≥ 2 weeks within 30 days prior to study screening, or are anticipated during study participation;
14. Any active cancer undergoing treatment ≤ 30 days prior to wound management visit #1 of the run-in period, or is anticipated during study participation;
15. Treatment with chemotherapy within 30 days of the first study wound management visit of the run-in period, or is anticipated during study participation;
16. Diabetics with poor metabolic control, defined as HbA1c ≥ 12.0%, within 30 days of visit #1 of the run-in period;
17. Participation in an investigational device, biologic, or drug study currently or within 30 days of study wound management visit #1 of the run-in period;
18. Prior use of any advanced skin substitute product on the index ulcer within 60 days of visit #1 of the run-in period;
19. Index ulcer was continued to be treated after visit #1 of the run-in period and/or anticipate treatment during study participation with any of the following prohibited therapies:

    1. Biomedical or topical growth factor;
    2. Topical steroids applied to the index ulcer surface;
    3. On medications that are considered immune system modulators that could affect graft incorporation;
    4. Scarlet red dressing;
    5. Dakin's solution;
    6. Mafenide acetate;
    7. Tincoban;
    8. Zinc sulfate;
    9. Povidone-iodine solution;
    10. Polymyxin/nystatin;
    11. Chlorhexidine;
20. Patient is taking a cyclooxygenase-2 inhibitor (COX-2 inhibitor); such as, celecoxib (Celebrex, Consensi, Elyxyb), valdecoxib (Bextra), amlodipine (Consensi);
21. Patient has serum creatinine \> 2.5 mg/dL within 30 days of study wound management visit #1 of the run-in period;
22. Autoimmune connective tissue disease;
23. End stage renal disease (ESRD);
24. Presence of any condition which would seriously compromise the subject's ability to complete this study;
25. Known history of poor adherence to medical therapy and/or clinic appointments;
26. Pregnant, or planning to become pregnant during the study;
27. Life expectancy \< 1 year.

Where this trial is running

San Francisco, California and 1 other locations

• Center for Clinical Research Inc. — San Francisco, California, United States (RECRUITING)
• ILD Research Center — Vista, California, United States (RECRUITING)

Study contacts

• Study coordinator: Cyaandi Dove, DPM

Conditions: Diabetic Foot Ulcer, amniotic membrane allograft, diabetic foot ulcer, DFU