Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06600724
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-09-16
Brief Title:
Modified Platform Trial Evaluating PpLHACM and SOC Versus SOC Alone in the Treatment of Nonhealing DFUs
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Multicenter Prospective Randomized Controlled Modified Platform Trial Evaluating PURION Processed Lyophilized Human AmnionChorion Membrane ppLHACM and Standard of Care Versus Standard of Care Alone in the Treatment of Nonhealing Diabetic Foot Ulcers
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CAMPAIGN
Brief Summary:
This study will evaluate two human amnionchorion membrane ppLHACM products and Standard of Care SOC versus SOC alone in the closure of nonhealing diabetic foot ulcers DFUs
Detailed Description:
The CAMPAIGN trial is evaluating PURION Processed Lyophilized Human AmnionChorion Membrane ppLHACM and Standard of Care versus Standard of Care alone in the treatment of Nonhealing Diabetic Foot Ulcers The study will evaluate two products EPIEFFECT and EPIXPRESS which are both ppLHACMs
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None