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

Diabetic Foot Ulcer Clinical Trial

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

Clinical Trial 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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06236750
Study type Interventional
Source MiMedx Group, Inc.
Contact Chief Medical Officer
Phone 770-651-9100
Email CTInquiries@mimedx.com
Status Recruiting
Phase N/A
Start date August 4, 2023
Completion date January 2027
View Details
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