Amnion grafts for hard-to-heal diabetic foot and venous leg ulcers

A Multicenter Hybrid Platform Trial Comparing the Effects of a Prospective Cohort Treated With a Tri- Layer Amnion Graft or a Single Layer Amnion Graft to a Coarsened Exact Matched Retrospective Control Cohort of Patients With Hard-to-heal DFUs and VLUs

This study will test whether two types of amnion grafts, added to standard wound care, help hard-to-heal diabetic foot and venous leg ulcers heal better.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 165 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Capsicure, LLC (Research network)
• Locations: 7 sites (Oxnard, California and 6 other locations)
• Trial ID: NCT07046767 on ClinicalTrials.gov

What this trial studies

This is a multicenter hybrid platform, randomized two-arm prospective study comparing a tri-layer amnion graft and a single-layer amnion graft as adjuncts to standard of care, with a coarsened exact matched retrospective control cohort. Participants have nonhealing diabetic foot ulcers or venous leg ulcers of at least four weeks' duration that showed less than 50% reduction in wound area with standard therapies. Treatments are applied alongside routine wound care (debridement, moisture balance, infection control, offloading, and compression) and outcomes are followed in real-world clinic settings. The design aims to capture effectiveness across diverse care environments rather than in narrowly controlled trials.

Who should consider this trial

Good fit: Adults (18+) with a diabetic foot ulcer or venous leg ulcer at least four weeks old, 2–25 cm2 in size, and with less than 50% reduction in area over the prior four weeks are the intended candidates.

Not a fit: Patients whose wounds are already improving rapidly with standard care, pregnant or breastfeeding individuals, or those recently treated with engineered tissue/scaffold products are unlikely to benefit or are excluded.

Why it matters

Potential benefit: If successful, these grafts could help stubborn ulcers close faster and reduce complications like infection and the need for amputation when used with standard care.

How similar studies have performed: Other placental/amnion-derived graft products have shown promising results in prior trials and case series, but high-quality randomized and real-world comparative data remain limited.

Eligibility criteria

Inclusion Criteria:

1. Male or female 18 years of age and older
2. 2\. Subjects having a non-healing venous leg ulcer or diabetic foot ulcer of \>4 weeks duration and visible signs of healing objectively, less than 50% reduction in wound size in the last 4 weeks
3. Subjects' wound size is minimum of 2 cm2 and maximum of 25cm2
4. If the subject has more than one eligible wound the largest wound will be selected (the index wound)
5. Subject is able and willing to follow the protocol requirements
6. Subject has signed informed consent

Exclusion Criteria:

1. Inability to adhere to the study protocol or study visit schedule
2. Pregnancy
3. Child-bearing potential without appropriate contraception
4. Lactation
5. Treatment of the wound with engineered tissue or other scaffold materials within 30 days preceding the first treatment visit.
6. Visible signs of improvement in the four weeks before randomisation (defined objectively as a 50% reduction in surface area in the four weeks before enrolment)
7. The subject has other concurrent conditions that in the opinion of the investigator may compromise subject safety
8. Known contraindications to the use of amniotic tissue grafts
9. The index ulcer shows clinical signs and symptoms of wound infection needing treatment with local or systemic antimicrobials or antibiotics

Where this trial is running

Oxnard, California and 6 other locations

• FOMAT Medical Research — Oxnard, California, United States (Recruiting)
• Solutions Medical Research — Coral Gables, Florida, United States (Recruiting)
• Nova Medical Services - Research Division LLC — Miami, Florida, United States (Recruiting)
• Indiana University Health Methodist Hospital — Indianapolis, Indiana, United States (Recruiting)
• St. Louis Foot and Ankle, LLC — St Louis, Missouri, United States (Recruiting)
• Jevlos Health, Inc — Syosset, New York, United States (Recruiting)
• Hope Vascular and Podiatry — Houston, Texas, United States (Recruiting)

Study contacts

• Study coordinator: Marissa Docter, RN, BSN, MD

Conditions Diabetic Foot Ulcer; Venous Leg Ulcer; Wound; Foot; DCF; VLU; Venus Leg Ulcer