Observing the use of amnion/chorion membrane for chronic wounds
A Post-Marketing Surveillance to Observe the Safety and Efficacy of Dehydrated Human Amnion/Chorion Membrane (DHACM) Wound Graft in the Management of Non-Ischemic Chronic Wounds
This study is testing if a new treatment using a special membrane can help people with stubborn diabetic foot ulcers and venous leg ulcers heal better than with standard care.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 75 (estimated) |
| Sex | All |
| Sponsor | MiMedx Group, Inc. Industry-sponsored |
| Locations | 5 sites (Kobe, Hyōgo and 4 other locations) |
| Trial ID | NCT06236750 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the efficacy and safety of EPIFIX®, a dehydrated human amnion/chorion membrane, in treating intractable diabetic foot ulcers and venous leg ulcers. A total of 75 subjects will be enrolled across five plastic surgery sites in Japan, receiving weekly applications of EPIFIX for up to 12 weeks, followed by a 6-month follow-up period. The study focuses on patients whose ulcers have not improved significantly after conventional therapies.
Who should consider this trial
Good fit: Ideal candidates are patients with intractable diabetic foot ulcers or venous leg ulcers that have not shown at least a 50% reduction in size after 4 weeks of conventional treatment.
Not a fit: Patients with active infections, severe comorbidities, or ulcers that cannot be adequately treated or debrided will not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new effective option for patients suffering from chronic wounds that are resistant to standard therapies.
How similar studies have performed: Previous studies have shown promising results with similar approaches using amnion/chorion membranes for wound healing, indicating potential for success in this study.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Patients with intractable diabetic foot ulcers or venous leg ulcers that have not decreased in surface area by at least 50% after 4 weeks of conventional therapies, such as radical wound management (removal of necrotic tissue, infection control, wound cleansing, etc.), glycemic control for diabetic foot ulcers, compression therapy for venous stasis ulcers and moist therapy using wound dressing materials. Exclusion Criteria: 1. Areas of active infection or latent infection. 2. Patients with disorders that would cause an intolerable risk of postoperative complications. 3. Ulcers that cannot be sufficiently debrided. 4. Ulcers that, after debridement, have blood flow disorders where wound bed necrosis progresses at an early stage. 5. Wound surfaces with multiple ulcer surfaces and exposed bone, and no blood flow in the wound bed. 6. Patients with hypersensitivity to the aminoglycoside antibiotics used during manufacturing.
Where this trial is running
Kobe, Hyōgo and 4 other locations
- Kobe University Hospital — Kobe, Hyōgo, Japan (Recruiting)
- Saitame Medical University Hospital — Iruma-gun, Saitama, Japan (Recruiting)
- Juntendo University Hospital — Bunkyō-Ku, Tokyo, Japan (Recruiting)
- Kyorin University Hospital — Mitaka-shi, Tokyo, Japan (Recruiting)
- Tokyo Medical University Hospital — Shinjuku-Ku, Tokyo, Japan (Recruiting)
Study contacts
- Study coordinator: Chief Medical Officer
- Email: CTInquiries@mimedx.com
- Phone: 770-651-9100
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.