Ignite Creation Date:
2024-10-25 @ 7:49 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06557122
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-12
Brief Title:
Clinical Study to Compare Two Skin Substitute Categories for Their Effectiveness to Treat Diabetic Foot Ulcers
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Randomized Controlled Clinical Trial Evaluating the Efficacy of a Unique Advanced Bioengineered Skin Substitute With Standard of Care Versus an Active Comparator With Standard of Care in the Treatment of Non-Healing Diabetic Foot Ulcers
Status:
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:
The purpose of this clinical evaluation is to collect patient outcome data on a commercially available 510K FDA cleared advanced skin substitute The commercially available product is Helicoll Advanced Skin Substitute
In this trial two groups of subjects with Wagner 1 diabetic foot ulcers DFUs will receive standard of care SOC treatment for their condition Half of the patients will have their SOC treatment with Epifix or Grafix and the other half will receive a 510K FDA cleared Helicoll Advanced Skin Substitute as the primary treatment The primary endpoint is the percentage wound area reduction of the target ulcer Secondary endpoints include the proportion of subjects that obtain complete closure over the 5-week treatment period the time to achieve complete wound closure of the target ulcer by the end of 5 weeks and mean number of IP applications
In this trial two groups of subjects with Wagner 1 diabetic foot ulcers DFUs will receive standard of care SOC treatment for their condition Half of the patients will have their SOC treatment with Epifix or Grafix and the other half will receive a 510K FDA cleared Helicoll Advanced Skin Substitute as the primary treatment The primary endpoint is the percentage wound area reduction of the target ulcer Secondary endpoints include the proportion of subjects that obtain complete closure over the 5-week treatment period the time to achieve complete wound closure of the target ulcer by the end of 5 weeks and mean number of IP applications
Detailed Description:
None
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