Ignite Creation Date:
2024-05-06 @ 8:03 PM
Last Modification Date:
2024-10-26 @ 3:19 PM
Study NCT ID:
NCT06236750
Status:
RECRUITING
Last Update Posted:
2024-02-01
First Post:
2024-01-24
Brief Title:
Post-Marketing Surveillance of Dehydrated Human AmnionChorion Membrane DHACM in Non-Ischemic Chronic Wounds
Sponsor:
MiMedx Group Inc
Organization:
MiMedx Group Inc
Study Overview
Official Title:
A Post-Marketing Surveillance to Observe the Safety and Efficacy of Dehydrated Human AmnionChorion 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 amnionchorion 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:
None
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?:
None