NCT06140303

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

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: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: PolarityTE · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 1:1 ratio to SkinTE with SOC or SOC alone. Patients will be followed weekly for 6 months for wound closure.

Conditions

• Diabetic Foot

Interventions

Type	Name	Description
BIOLOGICAL	SkinTE	SkinTE is an Autologous Heterogeneous Skin Construct (AHSC), which is manufactured from a small piece of healthy full-thickness skin harvested from the patient at the time of randomization to the SkinTE arm. SkinTE is manufactured aseptically by PolarityTE following current Good Manufacturing Practice (cGMP). SkinTE is not cultured ex vivo; rather, it is returned to the provider expeditiously to maintain cellular viability. SkinTE includes various multicellular segments as a result of the manufacturing process. The different multicellular segments contain different types of skin cells, such as keratinocytes, dermal fibroblasts, dermal endothelial cells, and follicular cells, as well as extracellular matrix. The multicellular segments have a surface area-to-volume ratio for improved sustenance by imbibition prior to engraftment.
OTHER	Control	Standard care is defined in this protocol to include the following: * Debridement * Collagen dressing * Local offloading * Foam * Multi-layer compression dressing * Off-loading device such as a controlled ankle motion (CAM) boot

Timeline

• Start date: 2024-02-22
• Primary completion: 2025-12-31
• Completion: 2026-03-31
• First posted: 2023-11-18
• Last updated: 2025-07-11

Locations

23 sites across 1 country: United States

Regulatory

• FDA-regulated drug study