Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06562296
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-12
Brief Title:
Study Evaluating Several CAMPs in Nonhealing Diabetic Foot and Venous Leg Ulcers
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Multicenter Prospective Randomized Controlled Matriarch Trial Evaluating Several Cellular Acellular and Matrix-like Products CAMPs and Standard of Care Versus SOC Alone of Nonhealing Diabetic Foot and Venous Leg 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:
CAMPLIFE
Brief Summary:
The purpose of this study is to determine how well multiple CAMPs Cellular Acellular and Matrix-Like Products and Standard of Care work when compared to Standard of Care alone in achieving complete closure of diabetic foot and venous leg ulcers
Detailed Description:
Chronic wounds affect a significant percentage of patients over their lifetime For example diabetic foot ulcers DFU are a major health complication that affect up to 15 of individuals with diabetes mellitus over their lifetime The treatment of chronic wounds is extremely challenging as ulcers such as DFUs and Venous Leg Ulcers VLUs may not respond to standard of care SOC treatment and frequently become infected
Advanced wound products like CAMPs have become an important strategy in the treatment of these chronic wounds by trapping and binding the patients own cells to rebuild the dermis layer of the skin to aid in healing
This study will evaluate the clinical utility of Multiple CAMPs in the closure of diabetic foot ulcers and venous leg ulcers in subjects in comparison to Standard of Care treatment
Advanced wound products like CAMPs have become an important strategy in the treatment of these chronic wounds by trapping and binding the patients own cells to rebuild the dermis layer of the skin to aid in healing
This study will evaluate the clinical utility of Multiple CAMPs in the closure of diabetic foot ulcers and venous leg ulcers in subjects in comparison to Standard of Care treatment
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