Clinical trialNCT06140303Active, not recruitingPhase 3Interventional

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

SponsorPolarityTEEnrollment100Diabetic Foot

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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

clinicaltrials.gov ↗

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

Nikolai Sopko, MD, PhD
PolarityBio
Study Director
clinicaltrials.gov ↗

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

23 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States

Titan Clinical Research
Mesa, Arizona, United States
Center for Clinical Research
Castro Valley, California, United States
Limb Preservation Platform, Inc.
Fresno, California, United States
Angel City Research
Los Angeles, California, United States
Clemente Clinical Research Inc.
Los Angeles, California, United States
Center for Clinical Research
San Francisco, California, United States
Clemente Clinical Research Inc.
Santa Ana, California, United States
Ild Research
Vista, California, United States
Las Mercedes Medical Research, Inc.
Hialeah, Florida, United States
Doctors Research Network
Miami, Florida, United States
Dmi Research
Pinellas Park, Florida, United States
Barry University Clinical Research
Tamarac, Florida, United States
Fasma - Hagerstown
Hagerstown, Maryland, United States
Viable Research Management
Henderson, Nevada, United States
Northwell Health, Inc.
New Hyde Park, New York, United States
Mount Sinai West Hospital
New York, New York, United States
Leirt (lower Extremity Institute for Research and Therapy)
Boardman, Ohio, United States
Cutting Edge Research Llc
Circleville, Ohio, United States
Leirt (lower Extremity Institute for Research and Therapy)
East Liverpool, Ohio, United States
Cutting Edge Research Llc
Grove City, Ohio, United States
Perfizien Clinical Research Llc.
Houston, Texas, United States
Baylor Scott & White Health
Plano, Texas, United States
Foot and Ankle Specialists of the Mid-Atlantic
Salem, Virginia, United States

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

SkinTE

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 22 Feb 2024
Primary completion: 31 Dec 2025
Completion: 31 Mar 2026
Last update posted: 11 Jul 2025
Registered enrollment: 100
Registry id: NCT06140303

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.