Ignite Creation Date:
2024-05-06 @ 7:48 PM
Last Modification Date:
2024-10-26 @ 3:14 PM
Study NCT ID:
NCT06140303
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-02-12
First Post:
2023-11-15
Brief Title:
SkinTE for the Treatment of Wagner 1 Diabetic Foot Ulcers COVER DFUS II
Sponsor:
PolarityTE
Organization:
PolarityTE
Study Overview
Official Title:
Multi-Center Prospective Randomized Controlled Trial Evaluating SkinTE for the Treatment of Wagner 1 Diabetic Foot Ulcers Closure Obtained With Vascularized Epithelial Regeneration for DFUs With SkinTE II COVER DFUS II
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-02
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 assess the safety and efficacy of SkinTE for treatment of Wagner grade 1 diabetic foot ulcers
Detailed Description:
This study is a prospective multi-center randomized controlled trial RCT designed to assess the safety and efficacy of SkinTE with standard of care SOC dressings compared to SOC dressings alone wound debridement silicone dressing multi-layer compression dressings and offloading in the treatment of Wagner grade 1 diabetic foot ulcers DFUs ranging in size from 1 to 15 cm2 After being informed about the study and potential risks all patients giving written informed consent who meet eligibility criteria will undergo a 2-week screening period of SOC Patients meeting eligibility criteria following the screening period will be randomized in a single-blind manner closure confirmed by 3 blinded adjudicators in a 11 ratio to SkinTE with SOC or SOC alone Patients will be followed weekly for 6 months for wound closure
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None