Evaluating the COMS One device for treating diabetic foot ulcers

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Titan Clinical Research
  Mesa, Arizona, United States Recruiting
• Southern Arizona VA Health Care System
  Tucson, Arizona, United States Recruiting
• Center for Clinical Research Inc.
  Castro Valley, California, United States Recruiting
• VA Central California Healthcare
  Fresno, California, United States Recruiting
• Limb Preservation Platform, Inc.
  Fresno, California, United States Recruiting
• Angel City Research, Inc.
  Los Angeles, California, United States Recruiting

Study contacts

• Principal investigator: Aksone Nouvong, DPM — University of California, Los Angeles
• Study coordinator: Rejelle Williams
• Email: williams@piomic.com
• Phone: +41 44 244 19 78

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• THERAVEX Tissue Care Spray Plus for Healing of Skin Wounds and Ulcers

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• Pulsating electromagnetic field therapy for diabetic foot ulcers

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• Transverse tibial bone transport to help heal chronic diabetic foot ulcers

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.