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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Study contacts

• Study coordinator: Marissa Docter, RN, BSN, MD
• Email: mdocter@capsicure.com
• Phone: 512-571-2966

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.