Trial to Evaluate the Safety and Effectiveness of Treatment With COMS One Device in Subjects With Diabetic Foot Ulcers
NCT ID: NCT05758545
Last Updated: 2025-03-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
450 participants
INTERVENTIONAL
2023-06-19
2027-06-19
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Study to Assess the Safety of DERMASEAL for Diabetic Foot Ulcers
NCT05586542
Local Application of Combined Optical and Magnetic Stimulation (COMS) for Treatment of Chronic Wounds: Safety Evaluation
NCT03112395
Evaluating the Healing of Diabetic Foot Ulcers With Compounded Anti-Infective Irrigation Therapy
NCT05076955
Laser Therapy for Onychomycosis in Patients Wih Diabetes at Risk for Diabetic Foot Complications
NCT01996995
Omeza Products in Combination With Standard of Care for the Treatment of Diabetic Foot Ulcers
NCT05417425
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
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.
TREATMENT
DOUBLE
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.
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
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.
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.
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
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.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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
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%
22 Years
90 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
NAMSA
OTHER
Piomic Medical
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Aksone Nouvong, DPM
Role: PRINCIPAL_INVESTIGATOR
University of California, Los Angeles
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Titan Clinical Research
Mesa, Arizona, United States
Southern Arizona VA Health Care System
Tucson, Arizona, United States
Center for Clinical Research Inc.
Castro Valley, California, United States
Limb Preservation Platform, Inc.
Fresno, California, United States
Angel City Research, Inc.
Los Angeles, California, United States
UCLA Ronald Regan - Department of Surgery
Los Angeles, California, United States
Center for Clinical Research Inc.
San Francisco, California, United States
Center for Clinical Research Inc.
San Francisco, California, United States
ILD Research Center
Vista, California, United States
Bay Pines VA Healthcare System
Bay Pines, Florida, United States
University of Florida Health Jacksonville
Jacksonville, Florida, United States
Clever Medical Research LLC
Miami, Florida, United States
The Angel Medical Research Corporation
Miami Lakes, Florida, United States
Aiyan Diabetes Center
Augusta, Georgia, United States
Northwestern University Feinberg School of Medicine
Chicago, Illinois, United States
Rush University
Chicago, Illinois, United States
Gateway Clinical Trials
O'Fallon, Illinois, United States
Curalta Clinical Trials
Westwood, New Jersey, United States
Veteran Affairs of WNY Healthcare System
Buffalo, New York, United States
Northwell Comprehensive Wound Healing Center
Lake Success, New York, United States
UNC Medical Center
Chapel Hill, North Carolina, United States
The Ohio State University
Columbus, Ohio, United States
UPMC McKeesport
McKeesport, Pennsylvania, United States
Vanderbilt University Medical Center - Vanderbilt Wound Center
Nashville, Tennessee, United States
Richard C. Galperin DPM PA
Dallas, Texas, United States
HCA Healthcare Houston Medical Center
Houston, Texas, United States
Futuro Clinical Trials, LLC
McAllen, Texas, United States
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
Galiano RD, Li RA, Lantis JC, Oropallo A, Ulloa J, Iafrati M, Lavery LA, O'Connell J, Nouvong A, Cavalcante VMV. 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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
COMS_03
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.