Ignite Creation Date:
2025-12-24 @ 5:19 PM
Ignite Modification Date:
2026-01-02 @ 9:11 AM
Study NCT ID:
NCT06236750
Status:
RECRUITING
Last Update Posted:
2024-02-01
First Post:
2024-01-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Post-Marketing Surveillance of Dehydrated Human Amnion/Chorion Membrane (DHACM) in Non-Ischemic Chronic Wounds
Sponsor:
MiMedx Group, Inc.
Organization:
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Detailed 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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: