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NCT Number: NCT06236750

Post-Marketing Surveillance of Dehydrated Human Amnion/Chorion Membrane (DHACM) in 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.

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Key information

Conditions

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

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kobe University Hospital, Kobe, Hyōgo, Japan

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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.

Treatment and study plan

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.

Other names: DHACM

Primary outcomes

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

    Time frame: 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.

  2. Safety Endpoint: Incidence of Adverse Events

    Time frame: 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.

Other outcomes

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

    Time frame: 4 weeks, 8 weeks, and 12 weeks after initial application

    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.

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

    Time frame: 12 weeks after initial application

    The amount of time after initial DHACM application to achieve complete epithelialization of the wound.

  3. Efficacy Endpoint: Wound Recurrence for 6 months after Wound Closure

    Time frame: 6 months after wound closure

    The recurrence rate of healed ulcers will be monitored for 6 months after wound closure is achieved.

  4. Safety Endpoint: Incidence of Device Deficiencies

    Time frame: 9 months after initial application

    Incidence rate of device deficiencies, severity, and details in DHACM-treated patients during 12 weeks of treatment and 6 months of follow-up.

Study contacts

Contact information is provided by the study sponsor or research team.

Chief Medical Officer

CONTACT

[email protected]

770-651-9100

Sponsors and collaborators

Lead sponsor

MiMedx Group, Inc.

Industry

Collaborators

  • CMIC Co, Ltd. Japan

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Feb 1, 2024
Registry last updated
Feb 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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