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

Not Applicable

Recruiting

• Conditions: Venous Leg Ulcer; Diabetic Foot Ulcer
• Interventions: Device: EPIFIX

• Registration Number: NCT06236750
• Lead Sponsor: MiMedx Group, Inc.

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2023-08-04
• Status Verified: 2024-01
• Study First Submitted: 2024-01-24
• Study First Submitted QC: 2024-01-24
• Last Update Submitted: 2024-01-24
• Study First Posted: 2024-02-01
• Last Update Posted: 2024-02-01
• Primary Completion: 2027-01
• Study Completion: 2027-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 75

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patients with Non-Ischemic Chronic Wounds	EPIFIX	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.

Primary Outcome Measures

Name	Time	Method
Efficacy Endpoint: Healing of Ulcers at 4 Weeks, 8 Weeks, and 12 Weeks	4 weeks, 8 weeks, and 12 weeks after initial application	The percentage of patients to achieve wound closure at 4 weeks, 8 weeks, and 12 weeks after initial DHACM application, as a measure of healing rate.
Safety Endpoint: Incidence of Adverse Events	9 months after initial application	Incidence rate of adverse events in DHACM-treated patients during 12 weeks of treatment and 6 months of follow-up.

Trial Locations

Locations (5)

Kyorin University Hospital; 🇯🇵 Mitaka-shi, Tokyo, Japan

Kobe University Hospital; 🇯🇵 Kobe-shi, Hyogo, Japan

Tokyo Medical University Hospital; 🇯🇵 Shinjuku-Ku, Tokyo, Japan

Saitame Medical University Hospital; 🇯🇵 Iruma-gun, Saitama, Japan

Juntendo University Hospital; 🇯🇵 Bunkyō-Ku, Tokyo, Japan