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Evaluating the COMS One device for treating diabetic foot ulcers

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

Not applicable Interventional Piomic Medical · NCT05758545

This study is testing a new device called COMS One to see if it can help people with stubborn diabetic foot ulcers heal faster compared to a fake device while they also receive regular care.

Quick facts

PhaseNot applicable
Study typeInterventional
Enrollment450 (estimated)
Ages22 Years to 90 Years
SexAll
SponsorPiomic Medical Industry-sponsored
Drugs / interventionsprednisone
Locations30 sites (Mesa, Arizona and 29 other locations)
Trial IDNCT05758545 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to assess the safety and effectiveness of the COMS One device in patients with refractory diabetic foot ulcers (DFUs). It is a prospective randomized, double-blinded, sham-controlled trial designed to compare the wound closure rates of the COMS One device against a sham device over a 24-week period, alongside standard care. The primary goal is to determine the time to complete wound healing, defined as full skin re-epithelialization without drainage. Secondary objectives include safety confirmation and evaluation of various wound healing parameters and patient-reported outcomes.

Who should consider this trial

Good fit: Ideal candidates are adults aged 22 to 90 with Type 1 or Type 2 diabetes and a full-thickness diabetic foot ulcer located at or below the malleoli.

Not a fit: Patients with rapidly healing ulcers or those with Wagner Grade 3 ulcers or higher may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve healing rates for patients suffering from chronic diabetic foot ulcers.

How similar studies have performed: While this approach is novel, similar studies have shown promise in improving wound healing in diabetic foot ulcers.

Eligibility criteria

Show full inclusion / exclusion criteria 
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%

Where this trial is running

Mesa, Arizona and 29 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Diabetic Foot UlcerRefractory Diabetic Foot Ulcer
Last reviewed 2026-06-09 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.