Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06560502
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-15
Brief Title:
Modified Multi-Platform Trial Assessing Multiple CAMPs and SOC vs SOC Alone in the Treatment of DFU and VLUs
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Multicenter Prospective Randomized Controlled Modified Multi-Platform Matriarch Trial Evaluating Several Cellular Acellular and Matrix-like Products CAMPs and Standard of Care Versus Standard of Care Alone in the Management of DFUs and VLUs
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:
This is a multicenter prospective randomized controlled modified multi-platform matriarch trial evaluating several cellular acellular and matrix-like products CAMPs and standard of care versus standard of care alone in the management of nonhealing diabetic foot and venous leg ulcers
Detailed Description:
The purpose of this study is to determine the between-arm difference in the proportion of subjects achieving complete closure of nonhealing diabetic foot ulcers and venous leg ulcers with multiple CAMPs plus SOC versus SOC alone over 12 weeks using a modified dual platform Matriarch trial design
The initial plan is to evaluate five CAMPs per wound type however the modified platform design permits the inclusion of additional CAMPs
The initial plan is to evaluate five CAMPs per wound type however the modified platform design permits the inclusion of additional CAMPs
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