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New device uses light and magnets to heal diabetic foot wounds

NCT ID NCT05758545

Disease control Sponsor: Piomic Medical Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a portable device that uses red/near-infrared light and low-frequency magnetic pulses to help heal diabetic foot ulcers that haven't responded to standard care. About 450 adults with such ulcers will either receive the active device or a sham device, alongside usual wound care. The main goal is to see if the device leads to complete wound closure within 24 weeks.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Concurrent Optical and Magnetic Stimulation (COMS) device
What this could lead to
If it works, this could offer a new, non-invasive way to help heal stubborn diabetic foot ulcers, potentially reducing the risk of infection and amputation.
What could go wrong
This is a pivotal trial, but the device is still experimental. It may not work better than a sham device, and individual results can vary. There is no guarantee of healing.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 450 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2023

Expected to finish

Jun 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

22 to 90 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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%

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Conditions

The condition(s) this trial relates to.

Diabetic Foot

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Diabetic foot ulcer

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    26 sites. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Aiyan Diabetes Center

    RECRUITING

    Augusta, Georgia, 30907, United States

    Contact Email: •••••@•••••

  • Angel City Research, Inc.

    RECRUITING

    Los Angeles, California, 90010, United States

  • Bay Pines VA Healthcare System

    RECRUITING

    Bay Pines, Florida, 33744, United States

  • Center for Clinical Research Inc.

    RECRUITING

    Castro Valley, California, 94546, United States

  • Center for Clinical Research Inc.

    RECRUITING

    San Francisco, California, 94115, United States

  • Center for Clinical Research Inc.

    RECRUITING

    San Francisco, California, 94117, United States

  • Clever Medical Research LLC

    RECRUITING

    Miami, Florida, 33126, United States

  • Curalta Clinical Trials

    RECRUITING

    Westwood, New Jersey, 07675, United States

  • Futuro Clinical Trials, LLC

    RECRUITING

    McAllen, Texas, 78501, United States

  • Gateway Clinical Trials

    RECRUITING

    O'Fallon, Illinois, 62269, United States

  • HCA Healthcare Houston Medical Center

    RECRUITING

    Houston, Texas, 77004, United States

  • ILD Research Center

    RECRUITING

    Vista, California, 92081, United States

  • Limb Preservation Platform, Inc.

    RECRUITING

    Fresno, California, 93710, United States

  • MCR Health

    RECRUITING

    Bradenton, Florida, 34208, United States

  • Northwell Comprehensive Wound Healing Center

    WITHDRAWN

    Lake Success, New York, 11042, United States

  • Northwestern University Feinberg School of Medicine

    RECRUITING

    Chicago, Illinois, 60611, United States

  • Richard C. Galperin DPM PA

    RECRUITING

    Dallas, Texas, 75208, United States

  • Rush University

    WITHDRAWN

    Chicago, Illinois, 60612, United States

  • Southern Arizona VA Health Care System

    RECRUITING

    Tucson, Arizona, 85723, United States

  • The Angel Medical Research Corporation

    WITHDRAWN

    Miami Lakes, Florida, 33016, United States

  • The Ohio State University

    RECRUITING

    Columbus, Ohio, 43210, United States

  • Titan Clinical Research

    RECRUITING

    Mesa, Arizona, 85202, United States

  • UCLA Ronald Regan - Department of Surgery

    RECRUITING

    Los Angeles, California, 90095, United States

  • UNC Medical Center

    RECRUITING

    Chapel Hill, North Carolina, 27514, United States

  • UPMC McKeesport

    RECRUITING

    McKeesport, Pennsylvania, 15132, United States

  • University of Florida Health Jacksonville

    WITHDRAWN

    Jacksonville, Florida, 32209, United States

  • VA Central California Healthcare

    RECRUITING

    Fresno, California, 93703, United States

  • Vanderbilt University Medical Center - Vanderbilt Wound Center

    RECRUITING

    Nashville, Tennessee, 37232, United States

  • Veteran Affairs of WNY Healthcare System

    RECRUITING

    Buffalo, New York, 14215, United States

  • Vital Medical Research

    RECRUITING

    Sweetwater, Florida, 33174, United States

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