Ignite Creation Date:
2024-06-16 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06453187
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-11
First Post:
2024-06-07
Brief Title:
A Modified Platform Trial of Multiple CAMPs for the Management of Diabetic Foot Ulcers and Venous Leg Ulcers
Sponsor:
Integra LifeSciences Corporation
Organization:
Integra LifeSciences Corporation
Study Overview
Official Title:
Multicenter Prospective Randomized Controlled Platform Trial Assessing Clinical Utility of Cellular Acellular and Matrix-like Products CAMPs and Standard of Care vs SOC Alone in Hard-to-Heal Diabetic Foot and Venous Leg Ulcers
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
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:
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 hard-to-heal diabetic foot and venous leg ulcers
Detailed Description:
Hard to heal 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 hard to heal chronic wounds is extremely challenging as ulcers such as DFUs and Venous Leg Ulcers VLUs may not respond to standard of care SC treatment and frequently become infected
Advanced wound products like CAMPs have become an important strategy in the treatment of hard-to-heal chronic wounds by trapping and binding the patients own cells to rebuild the dermis layer of the skin to aid in healing
The study will evaluate the clinical utility of Multiple CAMPs in the closure of hard to heal 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 hard-to-heal chronic wounds by trapping and binding the patients own cells to rebuild the dermis layer of the skin to aid in healing
The study will evaluate the clinical utility of Multiple CAMPs in the closure of hard to heal 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?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None