Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06564831
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-15
Brief Title:
Evaluating the Efficacy of a Single Layer Placental-based Allograft and Standard of Care Versus Standard of Care
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Randomized Controlled Multicenter Clinical Trial Evaluating the Efficacy of a Single Layer Placental-based Allograft and Standard of Care Versus Standard of Care Alone in the Management of Nonhealing Diabetic Foot Ulcers
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
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:
None
Brief Summary:
A Randomized Controlled Multicenter Clinical Trial Evaluating the Efficacy of a Single Layer Placental-based Allograft and Standard of Care versus Standard of Care alone in the management of Nonhealing Diabetic Foot Ulcers
Detailed Description:
XCAMP is a multi-center randomized controlled clinical trial The study will evaluate the efficacy of a single layer amniotic membrane SLAM and standard of care SOC versus SOC alone in the closure of nonhealing diabetic foot ulcers DFUs XWRAP is an allograft membrane derived from human amniotic tissue Designed to act as a protective barrier it is effective for DFUs venous leg ulcers VLUs and pressure ulcers 13 The processing of XWRAP is designed to preserve the structural integrity of the amniotic epithelial membrane 13 The product is screened and tested in a Clinical Laboratory Improvement Amendment CLIA certified lab that meets or exceeds AATB criteria 13
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