Observing the use of amnion/chorion membrane for chronic wounds

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 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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Tracking the healing of chronic wounds with a special dressing

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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.