Clinical trialNCT05372809TerminatedPhase 3Interventional

Multi-Center, Prospective, Randomized Controlled Trial Evaluating SkinTE® in the Treatment of Wagner 2 DFUs

SponsorPolarityTEEnrollment42Diabetic 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 2 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.

David Armstrong, DPM, MD, PhD
University of Southern California
Study Chair
clinicaltrials.gov ↗
Lawrence Lavery, DPM
University of Texas
Principal Investigator
clinicaltrials.gov ↗
Nikolai Sopko, MD, PhD
PolarityTE
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

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

United States

Limb Preservation Platform, Inc
Fresno, California, United States
la Foot and Ankle Clinic
Los Angeles, California, United States
Royal Research, Corp
Hollywood, Florida, United States
Barry University Clinical Research
Tamarac, Florida, United States
Gateway Clinical Trials
O'Fallon, Illinois, United States
Boston Medical Center
Boston, Massachusetts, United States
Mount Sinai West
New York, New York, United States
Northwell Health
New York, New York, United States
University of Texas Southwestern Wound Care Clinic
Dallas, Texas, United States
Va North Texas Health Care System
Dallas, Texas, United States
Futuro Clinical Trials, Llc
McAllen, Texas, United States
Baylor Scott & White Research Institute - Plano
Plano, Texas, United States
Foot and Ankle Institute
St. George, Utah, 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: 28 Apr 2022
Primary completion: 21 Feb 2024
Completion: 21 Feb 2024
Last update posted: 26 Feb 2024
Registered enrollment: 42
Registry id: NCT05372809

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.