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

February 12, 2026 updated by: Piomic Medical

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Primary Objective:

The COMS One Therapy System is intended to promote wound healing in chronic DFUs. As part of the clinical investigation, the primary objective is to determine time to complete wound healing, defined as complete skin re-epithelialization without drainage confirmed by 2 consecutive trial visits 2 weeks apart.

Secondary Objectives:

Secondary objectives are confirmation of safety and assessment of wound healing parameters as well as subject and site reported outcomes.

A total of 450 subjects with refractory DFU will be screened. It is expected that 50% of subjects will be excluded from the trial if either of the following occurs between screening and randomization: >30% wound closure over a period of 2 weeks or >50% wound closure over a period of 4 weeks (measured post-debridement). The remaining 224 subjects will be randomized into two groups (112 Subjects Sham device treated; 112 Subjects COMS One device treated) to account for approximately 10% missing data due to early trial withdrawal or missed endpoint assessment.

Study Type

Interventional

Enrollment (Estimated)

450

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Arizona
      • Mesa, Arizona, United States, 85202
      • Tucson, Arizona, United States, 85723
        • Recruiting
        • Southern Arizona VA Health Care System
        • Contact:
        • Principal Investigator:
          • Jodi Walters, DPM
    • California
      • Castro Valley, California, United States, 94546
        • Recruiting
        • Center for Clinical Research Inc.
        • Contact:
        • Principal Investigator:
          • Alexander Reyzelman, DPM
      • Fresno, California, United States, 93710
        • Recruiting
        • Limb Preservation Platform, Inc.
        • Contact:
        • Principal Investigator:
          • Shawn M. Cazzell, DPM
      • Fresno, California, United States, 93703
        • Recruiting
        • VA Central California Healthcare
        • Contact:
        • Principal Investigator:
          • Viraj Pandit, MD
      • Los Angeles, California, United States, 90010
        • Recruiting
        • Angel City Research, Inc.
        • Principal Investigator:
          • Felix Sigal, DPM
        • Contact:
      • Los Angeles, California, United States, 90095
        • Recruiting
        • UCLA Ronald Regan - Department of Surgery
        • Principal Investigator:
          • Vincent Rowe, MD
        • Contact:
      • San Francisco, California, United States, 94117
        • Recruiting
        • Center for Clinical Research Inc.
        • Contact:
        • Principal Investigator:
          • Alexander Reyzelman, DPM
      • San Francisco, California, United States, 94115
        • Recruiting
        • Center for Clinical Research Inc.
        • Principal Investigator:
          • Alexander Reyzelman, DPM
        • Contact:
      • Vista, California, United States, 92081
        • Recruiting
        • ILD Research Center
        • Contact:
        • Principal Investigator:
          • Dean Vayser, DPM
    • Florida
      • Bay Pines, Florida, United States, 33744
        • Recruiting
        • Bay Pines VA Healthcare System
        • Principal Investigator:
          • Melissa Abercrombie, DMP
        • Contact:
      • Bradenton, Florida, United States, 34208
        • Recruiting
        • MCR Health
        • Contact:
        • Principal Investigator:
          • Chrisbel Dafeampekor, DPM
      • Jacksonville, Florida, United States, 32209
        • Withdrawn
        • University of Florida Health Jacksonville
      • Miami, Florida, United States, 33126
      • Miami Lakes, Florida, United States, 33016
        • Withdrawn
        • The Angel Medical Research Corporation
      • Sweetwater, Florida, United States, 33174
        • Recruiting
        • Vital Medical Research
        • Principal Investigator:
          • Deeva Frankel, DPM
        • Contact:
    • Georgia
      • Augusta, Georgia, United States, 30907
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Recruiting
        • Northwestern University Feinberg School of Medicine
        • Principal Investigator:
          • Robert Galiano, MD
        • Contact:
      • Chicago, Illinois, United States, 60612
        • Withdrawn
        • Rush University
      • O'Fallon, Illinois, United States, 62269
        • Recruiting
        • Gateway Clinical Trials
        • Contact:
        • Principal Investigator:
          • Christopher Anderson, DPM
    • New Jersey
      • Westwood, New Jersey, United States, 07675
        • Recruiting
        • Curalta Clinical Trials
        • Contact:
        • Principal Investigator:
          • Vincent Giacalone, DPM
    • New York
      • Buffalo, New York, United States, 14215
        • Recruiting
        • Veteran Affairs of WNY Healthcare System
        • Contact:
        • Principal Investigator:
          • Andrew Puckett, DPM
      • Lake Success, New York, United States, 11042
        • Withdrawn
        • Northwell Comprehensive Wound Healing Center
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27514
        • Recruiting
        • UNC Medical Center
        • Principal Investigator:
          • Stephen Heisler, DPM
        • Contact:
    • Ohio
      • Columbus, Ohio, United States, 43210
        • Recruiting
        • The Ohio State University
        • Principal Investigator:
          • Jonathan Wisler, MD
    • Pennsylvania
      • McKeesport, Pennsylvania, United States, 15132
        • Recruiting
        • UPMC McKeesport
        • Contact:
        • Principal Investigator:
          • Sashwati Roy, PhD
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Recruiting
        • Vanderbilt University Medical Center - Vanderbilt Wound Center
        • Principal Investigator:
          • Mark Iafrati, MD
        • Contact:
        • Contact:
    • Texas
      • Dallas, Texas, United States, 75208
        • Recruiting
        • Richard C. Galperin DPM PA
        • Principal Investigator:
          • Richard C. Galperin, DPM
        • Contact:
      • Houston, Texas, United States, 77004
        • Recruiting
        • HCA Healthcare Houston Medical Center
        • Principal Investigator:
          • Kristofer Charlton-Ouw, MD
        • Contact:
      • McAllen, Texas, United States, 78501
        • Recruiting
        • Futuro Clinical Trials, LLC
        • Principal Investigator:
          • Joseph Caporusso, DPM
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

22 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Subjects are male or female, ≥22 and ≤90 years of age
  2. Female subjects of childbearing potential must be willing to use acceptable methods of contraception (birth control pills, barriers, or abstinence) starting at screening and throughout the duration of their study participation.
  3. The participant (or LAR if applicable) must be able to understand and sign the informed consent form (ICF) and comply with requirements set in the protocol including trial visits, trial treatment and dressing regimens and compliance with required offloading device (if applicable)
  4. Type 1 or Type 2 diabetes mellitus
  5. Presence of one full-thickness DFU located at or below the malleoli (If the subject has more than one DFU that meets eligibility criteria, the investigator will designate one DFU as the target DFU to be treated in the trial)
  6. Wagner Grade 1 or 2 (without bone exposure)
  7. There is a minimum 2 cm margin between the target DFU and any other ulcer on that same foot, post-debridement
  8. Target DFU duration >30 days and <52 weeks
  9. Target DFU area between 0.5 - 25 cm2 at screening (Target DFU is ≥ 0.5cm2 after debridement at start of Run-In Phase)
  10. Adequate vascular perfusion of the target limb (same limb as where the target DFU is located) as evidenced by: either a skin perfusion pressure (SPP) measurement of ≥30mmHg OR an ankle-brachial index (ABI) >0.7 but less than 1.2 or a toe-brachial index (TBI) >0.4 but less than 1.1 or a transcutaneous oxygen pressure (TcPO2) >40mmHg

Exclusion Criteria:

  1. Known pregnancy or lactating
  2. Active skin cancer, a history of skin cancer or any other localized cancer, precancerous lesions or large moles in the areas to be treated.
  3. Subject who is taking any medications the Investigator believes may interfere with healing of the target DFU
  4. Subject who is currently undergoing treatment for an active systemic infection, including osteomyelitis
  5. Wagner Grade 3, 4 or 5
  6. Participation in another trial with investigational drug or device within the 30 days preceding and during the present trial
  7. Any co-morbid medical condition which places the subject at unreasonable risks in the opinion of the Investigator
  8. Subject has chronic renal insufficiency requiring dialysis (end stage renal disease)
  9. Subject is being treated with systemic corticosteroids (prednisone, dexamethasone, hydrocortisone, methylprednisolone, or similar) >10mg/day for more than 10 days or any dose >30 days
  10. For subjects in the 2-Week Run-In Phase: more than 30% closure of target DFU at Screening Run-In Phase Visit I or Randomization/Baseline Visit or more than 50% closure of target DFU between the 2 Week Historical Period and Randomization/Baseline Visit (measured post-debridement)
  11. For subjects in the 4-Week Run-In Phase: more than 30% closure of target DFU at Screening Run-In Visit II or between Screening Run-In Phase Visit II and Randomization/Baseline Visit or more than 50% closure of target DFU between Screening Run-In Phase Visit I and Randomization/Baseline Visit (measured post-debridement)

  12. Blood chemistry or counts values as follows (based on subject's medical files):

    1. Pre-albumin <10 mg/dL OR albumin <2.8 g/dL
    2. Serum BUN >60 mg/dL
    3. Serum creatinine >4.0 mg/dL
    4. WBC <2.0 x 109/L
    5. Hemoglobin <8.0 g/dL
    6. Absolute neutrophil <1.0 x 109/L
    7. Platelet count <50 x 109/L
    8. HbA1C >12%

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: COMS One device

The COMS One device is the housing unit for the user controls, displays and functions including embedded software, lithium-ion battery, optical (LEDs) and a magnetic stimulation coil. The COMS One device is reusable (the component can be used on multiple subjects and is cleaned between uses).

The COMStouch is a sterile single-use component. The COMStouch provides a base and sterile barrier for the COMS One device.

The COMSfix component is a self-adhesive single-use strap used to hold the COMS One device and COMStouch components in place during treatment.
Device: COMS One device
The COMS One device incorporates technologies for optical and magnetic stimulation. The optical stimulation component is designed to emit light by two types of light emitting diodes (LEDs) in the wavelength of 660 nm (red) and 830 nm (near infrared) range of the electromagnetic spectra. The magnetic stimulation component is generated by a coil emitting pulse modulated magnetic fields in the extremely low frequency (ELF) range of the electromagnetic spectra. The COMS One is a lightweight, portable device. The device is locally applied via a single use disposable component (COMStouch) that provides a base and sterile barrier for the unit. The device is attached via a single use strap (COMSfix). The device has been slightly adapted in order to make sure blinding is achieved/maintained. The specific feature that has been modified for the purpose of blinding is sensor detecting whether the device is lying on the skin.
Other Names:
  • Concurrent Optical and Magnetic Stimulation
Sham Comparator: Sham device

The sham device is the housing unit for the user controls, displays and functions including embedded software, lithium-ion battery, optical (LEDs) and a magnetic stimulation coil. The sham device is reusable (the component can be used on multiple subjects and is cleaned between uses).

The COMStouch is a sterile single-use component. The COMStouch provides a base and sterile barrier for the sham device.

The COMSfix component is a self-adhesive single-use strap used to hold the sham device and COMStouch components in place during treatment.
Device: Sham device
The Sham device is a lightweight, portable device. The device is applied via a single use disposable component (COMStouch) that provides a base and sterile barrier for the unit. The device is attached via a single use strap (COMSfix). The device has been slightly adapted in order to make sure blinding is achieved/maintained. The specific features that have been modified for the purposes of blinding include the following: 1) therapeutic output, and 2) sensor detecting whether the device is lying on the skin.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complete wound healing
Time Frame: 24 weeks post-application
The primary endpoint for this pivotal trial is time to complete wound closure from randomization through 24 weeks, which is defined as complete skin re-epithelialization without drainage confirmed by 2 consecutive trial visits 2 weeks apart.
24 weeks post-application

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Partial wound closure
Time Frame: 8 week, 12 week, 16 week, 20 week and 24 week
Percent Wound Area Reduction (PWAR) at week 8, 12, 16, 20, 24
8 week, 12 week, 16 week, 20 week and 24 week
Time to target diabetic foot ulcer re-occurrence
Time Frame: Up to 24 weeks
Time in number of days from randomization until re-occurrence of the target diabetic foot ulcer, assessed up to 24 weeks
Up to 24 weeks
Time to amputation
Time Frame: Up to 24 weeks
Time in number of days from randomization until amputation associated with the target diabetic foot ulcer, assessed up to 24 weeks
Up to 24 weeks
Pain assessment
Time Frame: Week 1, Week 8, Week 12, Week 24
Wong-Baker FACES Pain Rating Scale - patient chooses the face that best demonstrates the physical pain they are experiencing at four time points throughout study participation
Week 1, Week 8, Week 12, Week 24
Quality of life survey
Time Frame: Week 1, Week 8, Week 12, Week 24
36-Item Short Form Survey (SF-36) - health-related quality of life questionnaire that is completed by patients at four time points throughout study participation
Week 1, Week 8, Week 12, Week 24
Incidence of complete wound closure
Time Frame: 8 week, 12 week, 16 week, 20 week and 24 week
Incidence of complete wound closure after 8, 12, 16, 20, and 24 weeks, which is defined as complete skin re-epithelialization without drainage
8 week, 12 week, 16 week, 20 week and 24 week
Time to ≥50% wound area reduction
Time Frame: Through 24 weeks
Time in number of days until wound area is reduced by ≥50% compared to wound area at time of randomization
Through 24 weeks
Time to ≥90% wound area reduction
Time Frame: Through 24 weeks
Time in number of days until wound area is reduced by ≥90% compared to wound area at time of randomization
Through 24 weeks
Incidence of all related or serious adverse events
Time Frame: Up to week 12 and week 24
Number of subjects with one or more related adverse event or serious adverse events. Related adverse events are those judged by the investigator to be possibly, probably, or definitely related to the COMS One device or other trial procedures.
Up to week 12 and week 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Piomic Medical

Collaborators

NAMSA

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 19, 2023

Primary Completion (Estimated)

June 19, 2027

Study Completion (Estimated)

June 19, 2027

Study Registration Dates

First Submitted

February 9, 2023

First Submitted That Met QC Criteria

February 24, 2023

First Posted (Actual)

March 7, 2023

Study Record Updates

Last Update Posted (Actual)

February 17, 2026

Last Update Submitted That Met QC Criteria

February 12, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • COMS_03

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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