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

NCT05758545 | Recruiting DMC FDA Device

• 1 other identifier: COMS_03
• Study Type: interventional
• Target: 450
• Locations: 1 country
• Sites: 30

Brief Summary

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.

Conditions

Diabetic Foot Ulcer

Keywords

Refractory Diabetic Foot Ulcer (DFU)

Outcome Measures

Primary Outcomes (1)

• Complete wound healing

  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 Outcomes (9)

• Time to ≥50% wound area reduction

  Through 24 weeks

• Time to ≥90% wound area reduction

  Through 24 weeks

• Incidence of complete wound closure

  8 week, 12 week, 16 week, 20 week and 24 week

• Partial wound closure

  8 week, 12 week, 16 week, 20 week and 24 week

• Incidence of all related or serious adverse events

  Up to week 12 and week 24

Study Arms (2)

COMS One device

ACTIVE COMPARATOR

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

Sham device

SHAM COMPARATOR

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

Interventions

COMS One device 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.

Also known as: Concurrent Optical and Magnetic Stimulation

COMS One device

Sham device 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.

Sham device

Eligibility Criteria

• Age: 22 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects are male or female, ≥22 and ≤90 years of age
• 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.
• 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)
• Type 1 or Type 2 diabetes mellitus
• 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)
• Wagner Grade 1 or 2 (without bone exposure)
• There is a minimum 2 cm margin between the target DFU and any other ulcer on that same foot, post-debridement
• Target DFU duration \>30 days and \<52 weeks
• Target DFU area between 0.5 - 25 cm2 at screening (Target DFU is ≥ 0.5cm2 after debridement at start of Run-In Phase)
• 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

You may not qualify if:

• Known pregnancy or lactating
• Active skin cancer, a history of skin cancer or any other localized cancer, precancerous lesions or large moles in the areas to be treated.
• Subject who is taking any medications the Investigator believes may interfere with healing of the target DFU
• Subject who is currently undergoing treatment for an active systemic infection, including osteomyelitis
• Wagner Grade 3, 4 or 5
• Participation in another trial with investigational drug or device within the 30 days preceding and during the present trial
• Any co-morbid medical condition which places the subject at unreasonable risks in the opinion of the Investigator
• Subject has chronic renal insufficiency requiring dialysis (end stage renal disease)
• 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
• 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)
• 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)
• Blood chemistry or counts values as follows (based on subject's medical files):
• Pre-albumin \<10 mg/dL OR albumin \<2.8 g/dL
• Serum BUN \>60 mg/dL
• Serum creatinine \>4.0 mg/dL

Sponsors & Collaborators

• Piomic Medical: lead
• NAMSA: collaborator

Study Sites (30)

Titan Clinical Research

Mesa, Arizona, 85202, United States

RECRUITING

Southern Arizona VA Health Care System

Tucson, Arizona, 85723, United States

RECRUITING

Center for Clinical Research Inc.

Castro Valley, California, 94546, United States

RECRUITING

VA Central California Healthcare

Fresno, California, 93703, United States

RECRUITING

Limb Preservation Platform, Inc.

Fresno, California, 93710, United States

RECRUITING

Angel City Research, Inc.

Los Angeles, California, 90010, United States

RECRUITING

UCLA Ronald Regan - Department of Surgery

Los Angeles, California, 90095, United States

RECRUITING

Center for Clinical Research Inc.

San Francisco, California, 94115, United States

RECRUITING

Center for Clinical Research Inc.

San Francisco, California, 94117, United States

RECRUITING

ILD Research Center

Vista, California, 92081, United States

RECRUITING

Bay Pines VA Healthcare System

Bay Pines, Florida, 33744, United States

RECRUITING

MCR Health

Bradenton, Florida, 34208, United States

RECRUITING

University of Florida Health Jacksonville

Jacksonville, Florida, 32209, United States

WITHDRAWN

Clever Medical Research LLC

Miami, Florida, 33126, United States

RECRUITING

The Angel Medical Research Corporation

Miami Lakes, Florida, 33016, United States

WITHDRAWN

Vital Medical Research

Sweetwater, Florida, 33174, United States

RECRUITING

Aiyan Diabetes Center

Augusta, Georgia, 30907, United States

RECRUITING

Northwestern University Feinberg School of Medicine

Chicago, Illinois, 60611, United States

RECRUITING

Rush University

Chicago, Illinois, 60612, United States

WITHDRAWN

Gateway Clinical Trials

O'Fallon, Illinois, 62269, United States

RECRUITING

Curalta Clinical Trials

Westwood, New Jersey, 07675, United States

RECRUITING

Veteran Affairs of WNY Healthcare System

Buffalo, New York, 14215, United States

RECRUITING

Northwell Comprehensive Wound Healing Center

Lake Success, New York, 11042, United States

WITHDRAWN

UNC Medical Center

Chapel Hill, North Carolina, 27514, United States

RECRUITING

The Ohio State University

Columbus, Ohio, 43210, United States

RECRUITING

UPMC McKeesport

McKeesport, Pennsylvania, 15132, United States

RECRUITING

Vanderbilt University Medical Center - Vanderbilt Wound Center

Nashville, Tennessee, 37232, United States

RECRUITING

Richard C. Galperin DPM PA

Dallas, Texas, 75208, United States

RECRUITING

HCA Healthcare Houston Medical Center

Houston, Texas, 77004, United States

RECRUITING

Futuro Clinical Trials, LLC

McAllen, Texas, 78501, United States

RECRUITING

Related Publications (1)

• Galiano RD, Li RA, Lantis JC, Oropallo A, Ulloa J, Iafrati M, Lavery LA, O'Connell J, Nouvong A. The trial design of the concurrent optical and magnetic stimulation (COMS) therapy study for refractory diabetic foot ulcers (MAVERICKS): a multicenter, randomized, sham-controlled, double-blind investigational device exemption clinical study. Wounds. 2025 Aug;37(8):275-282. doi: 10.25270/wnds/25037.

  PMID: 40931367 DERIVED

MeSH Terms

Conditions

Diabetic Foot

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies

Study Officials

• Aksone Nouvong, DPM

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rejelle Williams

CONTACT

+41 44 244 19 78; williams@piomic.com

Bernard Laurel

CONTACT

+1-855-574-6642; laurel@piomic.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Permuted block randomization will be applied to generate randomization codes using a mix of blocks of size 2 and 4. Randomization will be stratified by site and age (\<65 years, ≥65 years). Both the COMS One device and the Sham device will be prepared to appear to be identical to the subject to achieve the double-blind purposes and each device will be given a unique serial identifier. To avoid assessment bias, each site will have an Inter-observer (blinded assessor) who will be blinded to treatment and perform and document all assessments of the target DFU evolution. Following target DFU assessment, the treatment will be performed by another assigned clinician, who will not have any involvement with the Inter-observer. Furthermore, both parties will be instructed not to discuss target DFU evolution or treatment with each other. This will provide an adequate level of masking to ensure that the trial is double-blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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. Following randomization, subjects will be assigned treatment with either COMS One device or the Sham device in conjunction with SOC. At least 50% of subjects are required to be 65 years or older at randomization. Prospective, randomized, double-blinded, placebo-controlled trials provide the most objective methods for analyzing the outcomes of multiple treatment groups. The blinded use of a sham device allows for a true comparison of COMS One treatment in conjunction with SOC to SOC alone.

Study Record Dates

• First Submitted: February 9, 2023
• First Posted: March 7, 2023
• Study Start: June 19, 2023
• Primary Completion (Estimated): June 19, 2027
• Study Completion (Estimated): June 19, 2027
• Last Updated: February 17, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (30)