Trial to Evaluate the Safety and Effectiveness of Treatment With COMS One Device in Subjects With Diabetic Foot Ulcers

Recruiting now · Not applicable · Has a placebo group

Conditions studied: Diabetic Foot Ulcer

In brief

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.

Key facts

Study ID

NCT05758545

Run by

Piomic Medical

People needed

450

Starts

2023-06-19

Expected to finish

2027-06-19

Last updated by the study team

2026-02-17

Who can join

Age: 22 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)
• 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

You may not qualify if…

• 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
• 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%

Where it is running

• Futuro Clinical Trials, LLC — McAllen, Texas, United States (enrolling)
• Southern Arizona VA Health Care System — Tucson, Arizona, United States (enrolling)
• Center for Clinical Research Inc. — Castro Valley, California, United States (enrolling)
• VA Central California Healthcare — Fresno, California, United States (enrolling)
• Limb Preservation Platform, Inc. — Fresno, California, United States (enrolling)
• Angel City Research, Inc. — Los Angeles, California, United States (enrolling)
• UCLA Ronald Regan - Department of Surgery — Los Angeles, California, United States (enrolling)
• Center for Clinical Research Inc. — San Francisco, California, United States (enrolling)
• Center for Clinical Research Inc. — San Francisco, California, United States (enrolling)
• ILD Research Center — Vista, California, United States (enrolling)
• Bay Pines VA Healthcare System — Bay Pines, Florida, United States (enrolling)
• MCR Health — Bradenton, Florida, United States (enrolling)
• Vanderbilt University Medical Center - Vanderbilt Wound Center — Nashville, Tennessee, United States (enrolling)
• Richard C. Galperin DPM PA — Dallas, Texas, United States (enrolling)
• HCA Healthcare Houston Medical Center — Houston, Texas, United States (enrolling)
• Titan Clinical Research — Mesa, Arizona, United States (enrolling)
• Clever Medical Research LLC — Miami, Florida, United States (enrolling)
• Vital Medical Research — Sweetwater, Florida, United States (enrolling)
• Aiyan Diabetes Center — Augusta, Georgia, United States (enrolling)
• Northwestern University Feinberg School of Medicine — Chicago, Illinois, United States (enrolling)
• Gateway Clinical Trials — O'Fallon, Illinois, United States (enrolling)
• Curalta Clinical Trials — Westwood, New Jersey, United States (enrolling)
• Veteran Affairs of WNY Healthcare System — Buffalo, New York, United States (enrolling)
• UNC Medical Center — Chapel Hill, North Carolina, United States (enrolling)
• The Ohio State University — Columbus, Ohio, United States (enrolling)

Full record on ClinicalTrials.gov

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