SkinTE® for the Treatment of Wagner 1 Diabetic Foot Ulcers (COVER DFUS II)

Status Not yet recruiting

Clinical Trial Summary

The purpose of this study is to assess the safety and efficacy of SkinTE for treatment of Wagner grade 1 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, 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 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	NCT06140303
Study type	Interventional
Source	PolarityTE
Contact	Ashlee Fishleigh
Phone	800-653-8031
Email	clinicalresearch@PolarityTE.com
Status	Not yet recruiting
Phase	Phase 3
Start date	February 2024
Completion date	December 2025

View Details

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