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
Status: Recruiting
Location: See all (5) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.
Eligibility
Participation Requirements
Sex: All
Healthy Volunteers: f
View:
• 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.
Locations
Other Locations
Japan
Juntendo University Hospital
RECRUITING
Bunkyō-ku
Saitame Medical University Hospital
RECRUITING
Iruma-gun
Kobe University Hospital
RECRUITING
Kobe
Kyorin University Hospital
RECRUITING
Mitaka-shi
Tokyo Medical University Hospital
RECRUITING
Shinjuku-ku
Contact Information
Primary
Chief Medical Officer
CTInquiries@mimedx.com
770-651-9100
Time Frame
Start Date: 2023-08-04
Estimated Completion Date: 2027-01
Participants
Target number of participants: 75
Treatments
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.
Related Therapeutic Areas
Sponsors
Collaborators: CMIC Co, Ltd. Japan
Leads: MiMedx Group, Inc.