Diabetic Foot UlcerMavericksNCT05758545
Trial to Evaluate the Safety and Effectiveness of Treatment With COMS One Device in Subjects With Diabetic Foot Ulcers
A study testing COMS One device in people with Diabetic Foot Ulcer, run by Piomic Medical at 30 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 22 to 90 years
- Conditions the study is for
- Diabetic Foot Ulcer
- What is being tested?
- COMS One device
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 450 participants
- Where
- 30 sitesUnited States
- Study dates
- 19 Jun 2023to 19 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Show all 10Show fewer
- 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
Who cannot join
- 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
Show all 20Show fewer
- 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
- WBC <2.0 x 109/L
- Hemoglobin <8.0 g/dL
- Absolute neutrophil <1.0 x 109/L
- Platelet count <50 x 109/L
- HbA1C >12%
Trial locations and contacts
30 sites in 1 country. Contact the study team or a site near you to ask about taking part.
30 sites in 1 country
United States30 sites, 26 recruiting
- Recruiting
Aiyan Diabetes Center
Augusta, Georgia, 30907
Vishnu Gardasu, office@aiyandiabetescenter.com
Janaki Nadarajah, DPM
- Recruiting
Bay Pines VA Healthcare System
Bay Pines, Florida, 33744
Ashlee Tavernier, 727 398 6661 ext. 17842, Ashlee.Tavernier@va.gov
Melissa Abercrombie, DMP
- Recruiting
MCR Health
Bradenton, Florida, 34208
Susan Chamberlain, RN, 941-920-9870, schamberlain@mcr.health
Chrisbel Dafeampekor, DPM
- Recruiting
Veteran Affairs of WNY Healthcare System
Buffalo, New York, 14215
Ann Galla, Ann.Galla@va.gov
Andrew Puckett, DPM
- Recruiting
Center for Clinical Research Inc.
Castro Valley, California, 94546
Maria Peralta, Maria@ccr-trials.com
Alexander Reyzelman, DPM
- Recruiting
UNC Medical Center
Chapel Hill, North Carolina, 27514
Kari Walls, kawalls@email.unc.edu
Stephen Heisler, DPM
- Recruiting
Northwestern University Feinberg School of Medicine
Chicago, Illinois, 60611
Tarifa Adam, tarifaadam2025@u.northwestern.edu
Robert Galiano, MD
- Withdrawn
Rush University
Chicago, Illinois, 60612
- Recruiting
The Ohio State University
Columbus, Ohio, 43210
Jonathan Wisler, MD
- Recruiting
Richard C. Galperin DPM PA
Dallas, Texas, 75208
Leisa Guerrero, drgfoc@yahoo.com
Richard C. Galperin, DPM
- Recruiting
VA Central California Healthcare
Fresno, California, 93703
Viraj Pandit, MD, 559-225-6100, viraj.pandit@va.gov
Viraj Pandit, MD
- Recruiting
Limb Preservation Platform, Inc.
Fresno, California, 93710
Destiny Blackstone, Destiny@LPPresearch.com
Shawn M. Cazzell, DPM
- Recruiting
HCA Healthcare Houston Medical Center
Houston, Texas, 77004
Brianna De Roche, Brianna.DeRoche@hcahealthcare.com
Kristofer Charlton-Ouw, MD
- Withdrawn
University of Florida Health Jacksonville
Jacksonville, Florida, 32209
- Withdrawn
Northwell Comprehensive Wound Healing Center
Lake Success, New York, 11042
- Recruiting
Angel City Research, Inc.
Los Angeles, California, 90010
Maira Jackson, maira@angelcityresearch.com
Felix Sigal, DPM
- Recruiting
UCLA Ronald Regan - Department of Surgery
Los Angeles, California, 90095
Marco Morcos, MMorcos@mednet.ucla.edu
Vincent Rowe, MD
- Recruiting
Futuro Clinical Trials, LLC
McAllen, Texas, 78501
Pedro Gonzalez, Pedro@futuroct.com
Joseph Caporusso, DPM
- Recruiting
UPMC McKeesport
McKeesport, Pennsylvania, 15132
Chelsea Fredrick, chf168@pitt.edu
Sashwati Roy, PhD
- Recruiting
Titan Clinical Research
Mesa, Arizona, 85202
Noreen Rana, nrana.alas@viableresearch.org
Yadwinder Dhillon, MD
- Recruiting
Clever Medical Research LLC
Miami, Florida, 33126
Margarita Hernandez, mhernandez@clevermedresearch.com
Heliodoro Ruiz, MD
- Withdrawn
The Angel Medical Research Corporation
Miami Lakes, Florida, 33016
- Recruiting
Vanderbilt University Medical Center - Vanderbilt Wound Center
Nashville, Tennessee, 37232
Celia Núñez, celia.m.nunez@vumc.org
Mena Azer, mena.n.azer@vumc.org
- Recruiting
Gateway Clinical Trials
O'Fallon, Illinois, 62269
Valerie Anderson, valerie@podiatry1st.com
Christopher Anderson, DPM
- Recruiting
Center for Clinical Research Inc.
San Francisco, California, 94115
Maria Paralta, Maria@ccr-trials.com
Alexander Reyzelman, DPM
- Recruiting
Center for Clinical Research Inc.
San Francisco, California, 94117
Maria Peralta, Maria@ccr-trials.com
Alexander Reyzelman, DPM
- Recruiting
Vital Medical Research
Sweetwater, Florida, 33174
Alejandro Morlan, APRN, 305-703-4414, alejandro.m@vitalmedicalresearch.com
Deeva Frankel, DPM
- Recruiting
Southern Arizona VA Health Care System
Tucson, Arizona, 85723
Lorrie Mills, 520-792-1450 ext. 1-4068, Lorrie.Mills@va.gov
Jodi Walters, DPM
- Recruiting
ILD Research Center
Vista, California, 92081
Eric Martinez, eric@ildresearch.com
Dean Vayser, DPM
- Recruiting
Curalta Clinical Trials
Westwood, New Jersey, 07675
Radhika Gajera, Rgajera@curalta.com
Vincent Giacalone, DPM
About this study
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
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.
Read the 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.
- Conditions
- Diabetic Foot Ulcer
- Being tested
- COMS One device, Sham device
- Keywords
- Refractory Diabetic Foot Ulcer (DFU)
- Medical subject headings
- Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
COMS One deviceDevice
Also called Concurrent Optical and Magnetic Stimulation
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 deviceDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Sham device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 weeks post-application
Secondary outcomes (9)
Time to ≥50% wound area reduction
Time in number of days until wound area is reduced by ≥50% compared to wound area at time of randomization
Measured: Through 24 weeks
Time to ≥90% wound area reduction
Time in number of days until wound area is reduced by ≥90% compared to wound area at time of randomization
Measured: Through 24 weeks
Incidence of complete wound closure
Incidence of complete wound closure after 8, 12, 16, 20, and 24 weeks, which is defined as complete skin re-epithelialization without drainage
Measured: 8 week, 12 week, 16 week, 20 week and 24 week
Partial wound closure
Percent Wound Area Reduction (PWAR) at week 8, 12, 16, 20, 24
Measured: 8 week, 12 week, 16 week, 20 week and 24 week
Incidence of all related or serious adverse events
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.
Measured: Up to week 12 and week 24
Time to target diabetic foot ulcer re-occurrence
Time in number of days from randomization until re-occurrence of the target diabetic foot ulcer, assessed up to 24 weeks
Measured: Up to 24 weeks
Time to amputation
Time in number of days from randomization until amputation associated with the target diabetic foot ulcer, assessed up to 24 weeks
Measured: Up to 24 weeks
Pain assessment
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
Measured: Week 1, Week 8, Week 12, Week 24
Quality of life survey
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
Measured: Week 1, Week 8, Week 12, Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2023
- Study start19 Jun 2023
- Primary completion19 Jun 2027 (estimated)
- Study completion19 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetic Foot UlcerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model 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. 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.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Piomic Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- NAMSA
- Responsible party
- Sponsor
- Investigators
- Aksone Nouvong, DPM, Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05758545
- Sponsor's protocol ID
- COMS_03
- Acronym
- Mavericks
- Status last verified
- Feb 2026
- First submitted
- 9 Feb 2023
- Last updated
- 17 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 40931367
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05758545
- Acronym / sponsor ID
- Mavericks / COMS_03
- Conditions
- Diabetic Foot Ulcer
- Keywords
- Refractory Diabetic Foot Ulcer (DFU)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- Piomic MedicalIndustry (pharma, biotech, devices)
- Collaborators
- NAMSA
- Study start
- 19 Jun 2023 (actual)
- Primary completion
- 19 Jun 2027 (estimated)
- Study completion
- 19 Jun 2027 (estimated)
- First posted
- 7 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model 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. 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.
| Arm | Type | Receives |
|---|---|---|
| COMS One device | Active comparator | Device: COMS One deviceThe 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. |
| Sham device | Sham comparator | Device: Sham deviceThe 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. |
Who may qualify
- Ages
- 22 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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)
Key exclusion criteria (20 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| COMS One deviceAlso: Concurrent Optical and Magnetic StimulationThe 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. | Device | COMS One device |
| Sham deviceThe 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. | Device | Sham device |
Primary outcome
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.
9 secondary outcomes
Time to ≥50% wound area reduction
Time frame: Through 24 weeks
Time to ≥90% wound area reduction
Time frame: Through 24 weeks
Incidence of complete wound closure
Time frame: 8 week, 12 week, 16 week, 20 week and 24 week
Partial wound closure
Time frame: 8 week, 12 week, 16 week, 20 week and 24 week
Incidence of all related or serious adverse events
Time frame: Up to week 12 and week 24
Time to target diabetic foot ulcer re-occurrence
Time frame: Up to 24 weeks
Time to amputation
Time frame: Up to 24 weeks
Pain assessment
Time frame: Week 1, Week 8, Week 12, Week 24
Quality of life survey
Time frame: Week 1, Week 8, Week 12, Week 24
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2026.
- Derived from this study: PubMed 40931367Galiano 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Aksone Nouvong, DPM principal investigator
University of California, Los Angeles
30 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing COMS One device in people with Diabetic Foot Ulcer, run by Piomic Medical at 30 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 30 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rejelle Williams (+41 44 244 19 78, williams@piomic.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete wound healing (time frame: 24 weeks post-application). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05758545, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2026.