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Post-Marketing Surveillance of Dehydrated Human Amnion/Chorion Membrane (DHACM) in Non-Ischemic Chronic Wounds

RecruitingNAAges any - anyAllMiMedx Group, Inc.
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In plain words

What the trial is, and whether it could suit you

The purpose of this survey is to observe the efficacy and safety of EPIFIX® dehydrated human amnion/chorion membrane (DHACM) for the treatment of intractable diabetic foot ulcers or venous leg ulcers.

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
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.
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What it tests

  • EPIFIX
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Where

5 sites
Kobe University Hospital
Kobe, Japan
Saitame Medical University Hospital
Iruma-gun, Japan
Juntendo University Hospital
Bunkyō-Ku, Japan
Kyorin University Hospital
Mitaka-shi, Japan
Tokyo Medical University Hospital
Shinjuku-Ku, Japan
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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