AMNIOHEAL RWE Trial: Amnion Grafts for Healing Hard-to-Heal Ulcers in RW Populations

Launched by CAPSICURE, LLC · Jun 23, 2025

Keywords

ClinConnect Summary

This clinical trial, called the AMNIOHEAL RWE Trial, is studying new ways to help heal hard-to-heal wounds on the feet and legs, specifically diabetic foot ulcers and venous leg ulcers. These types of wounds can be very slow to heal and may cause ongoing problems. The trial is comparing two types of treatments using special amnion grafts, which are layers of tissue that come from the amniotic sac (a protective layer around a baby during pregnancy) and can help wounds heal faster. Researchers will look at how well these grafts work compared to patients who received usual care in the past.

Adults 18 years and older who have a stubborn wound that has not improved much in the last month may be eligible to join. The wound must be between 2 and 25 square centimeters in size, and if someone has multiple wounds, the largest one will be studied. Participants will need to be able to follow the study’s schedule and agree to take part by signing a consent form. People who are pregnant, breastfeeding, or have recently received other advanced wound treatments won’t be able to join. If you take part, you can expect to receive one of the amnion graft treatments and have your wound monitored to see if it heals better compared to past patients. This study is not yet open for enrollment but aims to find better treatment options for people with difficult wounds.

Gender

ALL

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