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

NCT06236750 | Recruiting

• 1 other identifier: EFJP001
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 5

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.

Conditions

Diabetic Foot Ulcer; Venous Leg Ulcer

Outcome Measures

Primary Outcomes (2)

• Efficacy Endpoint: Healing of Ulcers at 4 Weeks, 8 Weeks, and 12 Weeks

  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.

  4 weeks, 8 weeks, and 12 weeks after initial application

• Safety Endpoint: Incidence of Adverse Events

  Incidence rate of adverse events in DHACM-treated patients during 12 weeks of treatment and 6 months of follow-up.

  9 months after initial application

Other Outcomes (4)

• Efficacy Endpoint: Reduction in Wound Size at 4 Weeks, 8 Weeks, and 12 Weeks

  4 weeks, 8 weeks, and 12 weeks after initial application

• Efficacy Endpoint: Time to Complete Wound Healing during 12 Weeks of Application

  12 weeks after initial application

• Efficacy Endpoint: Wound Recurrence for 6 months after Wound Closure

  6 months after wound closure

Study Arms (1)

Patients with Non-Ischemic Chronic Wounds

EXPERIMENTAL

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.

Device: EPIFIX

Interventions

EPIFIX DEVICE

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.

Also known as: DHACM

Patients with Non-Ischemic Chronic Wounds

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• MiMedx Group, Inc.: lead
• CMIC Co, Ltd. Japan: collaborator

Study Sites (5)

Kobe University Hospital

Kobe, Hyōgo, 650-0017, Japan

RECRUITING

Saitame Medical University Hospital

Iruma-gun, Saitama, 350-0495, Japan

RECRUITING

Juntendo University Hospital

Bunkyō-Ku, Tokyo, 113-8431, Japan

RECRUITING

Kyorin University Hospital

Mitaka-shi, Tokyo, 181-8611, Japan

RECRUITING

Tokyo Medical University Hospital

Shinjuku-Ku, Tokyo, 160-0023, Japan

RECRUITING

MeSH Terms

Conditions

Diabetic Foot; Varicose Ulcer

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies; Varicose Veins

Study Officials

• David Mason, MD

  MiMedx Group, Inc.

  STUDY DIRECTOR

Central Study Contacts

Chief Medical Officer

CONTACT

770-651-9100; CTInquiries@mimedx.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 24, 2024
• First Posted: February 1, 2024
• Study Start: August 4, 2023
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027
• Last Updated: February 1, 2024

Record last verified: 2024-01

Locations

JP (5)