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Multi-Center, Prospective, Randomized Controlled Trial Evaluating SkinTE® in the Treatment of Wagner 2 DFUs — COVER DFUs  

Diabetic Foot Clinical Trial

Official title:
Closure Obtained With Vascularized Epithelial Regeneration for DFUs With SkinTE®

Clinical Trial Summary

The purpose of this study is to assess the safety and efficacy of SkinTE for treatment of Wagner grade 2 diabetic foot ulcers.

Clinical Trial 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, collagen-alginate dressing, multi-layer compression dressings, and offloading) in the treatment of Wagner grade 2 diabetic foot ulcers (DFUs) ranging in size from 1 to 10 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 (blinded evaluator with closure confirmed by a blinded adjudicator) in a 1:1 ratio to SkinTE with SOC or SOC alone. Patients will be followed weekly for 6 months for wound closure. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05372809
Study type Interventional
Source PolarityTE
Contact
Status Terminated
Phase Phase 3
Start date April 28, 2022
Completion date February 21, 2024
View Details
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