NCT07222540

Expanded Access Program Evaluating SkinTE in the Treatment of Wagner 1 Diabetic Foot Ulcers

• Status: Temporarily Not Available
• Phase: —
• Study type: Expanded Access
• Enrollment: —
• Sponsor: PolarityTE · Industry
• Sex: All
• Age: —
• Healthy volunteers: —

Summary

The purpose of this EAP is to provide access to SkinTE® for patients with Wagner I Diabetic Foot Ulcers (DFUs). SkinTE® is an autologous investigational product created from a healthy full-thickness skin harvest. SkinTE is applied directly to the wound with the goal of promoting healing. In addition to providing treatment, the program will collect safety and efficacy data. This data will help us understand the potential risks and benefits of SkinTE® when used in a real-world setting. PolarityBio® provides research funding to the study site to support data collection.

Conditions

• DFU
• Neuropathic Diabetic Ulcer - Foot
• Diabetic Foot Disease

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 PolarityBio 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 contains multicellular aggregates that contain different types of skin cells, such as keratinocytes, dermal fibroblasts, dermal endothelial cells, and follicular cells, as well as extracellular matrix. The multicellular aggregates have a surface area-to-volume ratio for improved sustenance by imbibition prior to engraftment.

Timeline

• First posted: 2025-10-30
• Last updated: 2025-10-30