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

NCT06140303 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2025-07-11

No results posted yet for this study

Summary

The purpose of this study is to assess the safety and efficacy of SkinTE for treatment of Wagner grade 1 diabetic foot ulcers.

Conditions

  • Diabetic Foot

Interventions

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

Sponsors & Collaborators

  • Professional Education and Research Institute

    collaborator OTHER

  • PolarityTE

    lead INDUSTRY

Principal Investigators

  • Nikolai Sopko, MD, PhD · PolarityBio

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-02-22
Primary Completion
2025-12-31
Completion
2026-03-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06140303 on ClinicalTrials.gov