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Recruiting Not applicable Interventional

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

ClinicalTrials.gov ID: NCT05758545

Public ClinicalTrials.gov record NCT05758545. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced May 19, 2026, 1:40 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

Concurrent Optical and Magnetic Stimulation (COMS) for Treatment of Refractory Diabetic Foot Ulcer; a Prospective Randomized, Sham-controlled, Double-blinded, Pivotal Clinical Trial

Study identification

NCT ID
NCT05758545
Recruitment status
Recruiting
Study type
Interventional
Phase
Not applicable
Lead sponsor
Piomic Medical
Industry
Enrollment
450 participants

Conditions and interventions

Interventions

  • COMS One device Device
  • Sham device Device

Device

Eligibility (public fields only)

Age range
22 Years to 90 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Jun 18, 2023
Primary completion
Jun 18, 2027
Completion
Jun 18, 2027
Last update posted
Feb 16, 2026

2023 – 2027

United States locations

U.S. sites
30
U.S. states
12
U.S. cities
26
Facility City State ZIP Site status
Titan Clinical Research Mesa Arizona 85202 Recruiting
Southern Arizona VA Health Care System Tucson Arizona 85723 Recruiting
Center for Clinical Research Inc. Castro Valley California 94546 Recruiting
VA Central California Healthcare Fresno California 93703 Recruiting
Limb Preservation Platform, Inc. Fresno California 93710 Recruiting
Angel City Research, Inc. Los Angeles California 90010 Recruiting
UCLA Ronald Regan - Department of Surgery Los Angeles California 90095 Recruiting
Center for Clinical Research Inc. San Francisco California 94115 Recruiting
Center for Clinical Research Inc. San Francisco California 94117 Recruiting
ILD Research Center Vista California 92081 Recruiting
Bay Pines VA Healthcare System Bay Pines Florida 33744 Recruiting
MCR Health Bradenton Florida 34208 Recruiting
University of Florida Health Jacksonville Jacksonville Florida 32209 Withdrawn
Clever Medical Research LLC Miami Florida 33126 Recruiting
The Angel Medical Research Corporation Miami Lakes Florida 33016 Withdrawn
Vital Medical Research Sweetwater Florida 33174 Recruiting
Aiyan Diabetes Center Augusta Georgia 30907 Recruiting
Northwestern University Feinberg School of Medicine Chicago Illinois 60611 Recruiting
Rush University Chicago Illinois 60612 Withdrawn
Gateway Clinical Trials O'Fallon Illinois 62269 Recruiting
Curalta Clinical Trials Westwood New Jersey 07675 Recruiting
Veteran Affairs of WNY Healthcare System Buffalo New York 14215 Recruiting
Northwell Comprehensive Wound Healing Center Lake Success New York 11042 Withdrawn
UNC Medical Center Chapel Hill North Carolina 27514 Recruiting
The Ohio State University Columbus Ohio 43210 Recruiting
UPMC McKeesport McKeesport Pennsylvania 15132 Recruiting
Vanderbilt University Medical Center - Vanderbilt Wound Center Nashville Tennessee 37232 Recruiting
Richard C. Galperin DPM PA Dallas Texas 75208 Recruiting
HCA Healthcare Houston Medical Center Houston Texas 77004 Recruiting
Futuro Clinical Trials, LLC McAllen Texas 78501 Recruiting

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT05758545, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Feb 16, 2026 · Synced May 19, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT05758545 live on ClinicalTrials.gov.

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