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

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.

Study Overview

• Status: Recruiting
• Conditions: Diabetic Foot Ulcer; Venous Leg Ulcer
• Intervention / Treatment: Device: EPIFIX

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 Type: Interventional
• Enrollment (Estimated): 75
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Chief Medical Officer; Phone Number: 770-651-9100; Email: CTInquiries@mimedx.com

Study Locations

• Japan
  • Hyogo
    • Kobe-shi, Hyogo, Japan, 650-0017
      • Recruiting
      • Kobe University Hospital
  • Saitama
    • Iruma-gun, Saitama, Japan, 350-0495
      • Recruiting
      • Saitame Medical University Hospital
  • Tokyo
    • Bunkyō-Ku, Tokyo, Japan, 113-8431
      • Recruiting
      • Juntendo University Hospital
    • Mitaka-shi, Tokyo, Japan, 181-8611
      • Recruiting
      • Kyorin University Hospital
    • Shinjuku-Ku, Tokyo, Japan, 160-0023
      • Recruiting
      • Tokyo Medical University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Patients with Non-Ischemic Chronic Wounds; 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; 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.; Other Names: DHACM

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacy Endpoint: Reduction in Wound Size at 4 Weeks, 8 Weeks, and 12 Weeks	Wound size will be measured at 4 weeks, 8 weeks, and 12 weeks after initial DHACM application, and the percent reduction of wound area will be calculated compared to baseline (week 0), as a measure of rate of wound closure.	4 weeks, 8 weeks, and 12 weeks after initial application
Efficacy Endpoint: Time to Complete Wound Healing during 12 Weeks of Application	The amount of time after initial DHACM application to achieve complete epithelialization of the wound.	12 weeks after initial application
Efficacy Endpoint: Wound Recurrence for 6 months after Wound Closure	The recurrence rate of healed ulcers will be monitored for 6 months after wound closure is achieved.	6 months after wound closure
Safety Endpoint: Incidence of Device Deficiencies	Incidence rate of device deficiencies, severity, and details in DHACM-treated patients during 12 weeks of treatment and 6 months of follow-up.	9 months after initial application

Collaborators and Investigators

• Sponsor: MiMedx Group, Inc.
• Collaborators: CMIC Co, Ltd. Japan
• Investigators: Study Director: David Mason, MD, MiMedx Group, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): August 4, 2023
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027

Study Registration Dates

• First Submitted: January 24, 2024
• First Submitted That Met QC Criteria: January 24, 2024
• First Posted (Estimated): February 1, 2024

Study Record Updates

• Last Update Posted (Estimated): February 1, 2024
• Last Update Submitted That Met QC Criteria: January 24, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Skin Diseases; Endocrine System Diseases; Diabetic Angiopathies; Skin Ulcer; Diabetes Complications; Diabetes Mellitus; Diabetic Neuropathies; Foot Diseases; Varicose Veins; Diabetic Foot; Foot Ulcer; Ulcer; Leg Ulcer; Varicose Ulcer
• Other Study ID Numbers: EFJP001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No