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Post-Marketing Surveillance of Dehydrated Human Amnion/Chorion Membrane (DHACM) in Non-Ischemic Chronic Wounds
Sponsor: MiMedx Group, Inc.
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
Conditions
Interventions
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