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RECRUITING
NCT06236750
NA

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

Sponsor: MiMedx Group, Inc.

View on ClinicalTrials.gov

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.

Official 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

Key Details

Gender

All

Age Range

Any - Any

Study Type

INTERVENTIONAL

Enrollment

75

Start Date

2023-08-04

Completion Date

2027-01

Last Updated

2024-02-01

Healthy Volunteers

No

Interventions

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.

Locations (5)

Kobe University Hospital

Kobe, Hyōgo, Japan

Saitame Medical University Hospital

Iruma-gun, Saitama, Japan

Juntendo University Hospital

Bunkyō-Ku, Tokyo, Japan

Kyorin University Hospital

Mitaka-shi, Tokyo, Japan

Tokyo Medical University Hospital

Shinjuku-Ku, Tokyo, Japan