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

MiMedx

Status: Enrolling

Conditions: Venous Leg Ulcer; Diabetic Foot Ulcer

Treatments: Device: EPIFIX

Study type: Interventional

Funder types: Industry

Identifiers

NCT06236750

EFJP001

Details and patient eligibility

About

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.

Full description

The study will enroll 75 subjects diagnosed with intractable diabetic foot ulcers or venous leg ulcers at 5 plastic surgery sites in Japan. Subjects will be treated with weekly applications of EPIFIX for up to 12 weeks, followed by 6 months of follow-up.

Enrollment: 75 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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75 participants in 1 patient group

Patients with Non-Ischemic Chronic Wounds

Experimental group

Description:

Patients with intractable diabetic foot ulcer or venous leg ulcer that have not decreased in surface area by at least 50% after 4 weeks of conventional therapies.

Treatment:

Device: EPIFIX