Post-Marketing Surveillance of Dehydrated Human Amnion/Chorion Membrane (DHACM) in Non-Ischemic 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
MiMedx Group, Inc.
75 participants
Aug 4, 2023
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria1
- 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 Criteria6
- Areas of active infection or latent infection.
- Patients with disorders that would cause an intolerable risk of postoperative complications.
- Ulcers that cannot be sufficiently debrided.
- Ulcers that, after debridement, have blood flow disorders where wound bed necrosis progresses at an early stage.
- Wound surfaces with multiple ulcer surfaces and exposed bone, and no blood flow in the wound bed.
- Patients with hypersensitivity to the aminoglycoside antibiotics used during manufacturing.
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Interventions
EPIFIX® is an allograft derived from dehydrated human amnion/chorion membrane. EPIFIX is a medical device in Japan (Generic name: Material using human amniotic membrane for promotion of tissue healing) for use on intractable ulcers that are non-responsive to existing therapies for the purpose of promoting wound healing.
Locations(5)
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NCT06236750