Ignite Creation Date:
2025-12-25 @ 2:16 AM
Ignite Modification Date:
2026-03-02 @ 4:37 PM
Study NCT ID:
NCT02844660
Status:
COMPLETED
Last Update Posted:
2022-05-13
First Post:
2016-07-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dehydrated Human Umbilical Cord Allograft in the Management of Diabetic Foot Ulcers
Sponsor:
MiMedx Group, Inc.
Organization:
Study Overview
Official Title:
A Multicenter, Prospective, Randomized, Controlled, Comparative Parallel Study of Dehydrated Human Umbilical Cord Allograft in the Management of Diabetic Foot Ulcers
Status:
COMPLETED
Status Verified Date:
2020-11
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:
A Multicenter, Prospective, Randomized Controlled Comparative Parallel Study To determine the safety and effectiveness of EpiCord as compared to standard of care (SOC) therapy for the treatment of chronic, non-healing diabetic foot ulcers (DFUs)
Detailed Description:
This is a prospective, multicenter, randomized controlled trial. The trial will include approximately 66 subjects in up to 10 experienced clinical centers in the United States. The estimated enrollment period is 18 weeks (this includes the 2-week run-in period). After completing a 2-week screening period, the subjects will be followed for at least 16 weeks post-randomization.
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?: