Clinical trialNCT05758545RecruitingInterventional

Trial to Evaluate the Safety and Effectiveness of Treatment With COMS One Device in Subjects With Diabetic Foot Ulcers

SponsorPiomic MedicalEnrollment450Diabetic Foot Ulcer

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

The purpose of this clinical trial is to evaluate the safety and effectiveness of the treatment with the COMS One device in subjects with refractory diabetic foot ulcers (DFUs). The prospective randomized, double-blinded, sham-controlled trial is designed to demonstrate superiority of wound closure of the COMS One device to a sham-control device through 24 weeks post-application, when each is administered in conjunction with standard of care (SOC) in the treatment of DFUs.

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.

Aksone Nouvong, DPM
University of California, Los Angeles
Principal Investigator
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

30 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
Yadwinder Dhillon, MD
Recruiting
Southern Arizona Va Health Care System
Tucson, Arizona, United States
Jodi Walters, DPM
Recruiting
Center for Clinical Research Inc.
Castro Valley, California, United States
Alexander Reyzelman, DPM
Recruiting
Limb Preservation Platform, Inc.
Fresno, California, United States
Shawn M. Cazzell, DPM
Recruiting
Va Central California Healthcare
Fresno, California, United States
Viraj Pandit, MD
Recruiting
Angel City Research, Inc.
Los Angeles, California, United States
Felix Sigal, DPM
Recruiting
Ucla Ronald Regan - Department of Surgery
Los Angeles, California, United States
Vincent Rowe, MD
Recruiting
Center for Clinical Research Inc.
San Francisco, California, United States
Alexander Reyzelman, DPM
Recruiting
Center for Clinical Research Inc.
San Francisco, California, United States
Alexander Reyzelman, DPM
Recruiting
Ild Research Center
Vista, California, United States
Dean Vayser, DPM
Recruiting
Bay Pines Va Healthcare System
Bay Pines, Florida, United States
Melissa Abercrombie, DMP
Recruiting
Mcr Health
Bradenton, Florida, United States
Chrisbel Dafeampekor, DPM
Recruiting
University of Florida Health Jacksonville
Jacksonville, Florida, United States
Withdrawn
Clever Medical Research Llc
Miami, Florida, United States
Heliodoro Ruiz, MD
Recruiting
the Angel Medical Research Corporation
Miami Lakes, Florida, United States
Withdrawn
Vital Medical Research
Sweetwater, Florida, United States
Deeva Frankel, DPM
Recruiting
Aiyan Diabetes Center
Augusta, Georgia, United States
Janaki Nadarajah, DPM
Recruiting
Northwestern University Feinberg School of Medicine
Chicago, Illinois, United States
Robert Galiano, MD
Recruiting
Rush University
Chicago, Illinois, United States
Withdrawn
Gateway Clinical Trials
O'Fallon, Illinois, United States
Christopher Anderson, DPM
Recruiting
Curalta Clinical Trials
Westwood, New Jersey, United States
Vincent Giacalone, DPM
Recruiting
Veteran Affairs of Wny Healthcare System
Buffalo, New York, United States
Andrew Puckett, DPM
Recruiting
Northwell Comprehensive Wound Healing Center
Lake Success, New York, United States
Withdrawn
Unc Medical Center
Chapel Hill, North Carolina, United States
Stephen Heisler, DPM
Recruiting
the Ohio State University
Columbus, Ohio, United States
Jonathan Wisler, MD
Recruiting
Upmc Mckeesport
McKeesport, Pennsylvania, United States
Sashwati Roy, PhD
Recruiting
Vanderbilt University Medical Center - Vanderbilt Wound Center
Nashville, Tennessee, United States
Mark Iafrati, MD
Recruiting
Richard C. Galperin Dpm Pa
Dallas, Texas, United States
Richard C. Galperin, DPM
Recruiting
Hca Healthcare Houston Medical Center
Houston, Texas, United States
Kristofer Charlton-Ouw, MD
Recruiting
Futuro Clinical Trials, Llc
McAllen, Texas, United States
Joseph Caporusso, DPM
Recruiting

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

Drugs studied

No drug or biological interventions are in our data for this study — it may test a procedure, device or behavioral intervention, or the intervention list isn't in our current snapshot. See the registry record ↗. Why? →

Registration & key dates

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

Start: 19 Jun 2023
Primary completion: 19 Jun 2027
Completion: 19 Jun 2027
Last update posted: 17 Feb 2026
Registered enrollment: 450
Registry id: NCT05758545

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.