NCT05758545 Trial to Evaluate the Safety and Effectiveness of Treatment With COMS One Device in Subjects With Diabetic Foot Ulcers
| NCT ID | NCT05758545 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Piomic Medical |
| Condition | Diabetic Foot Ulcer |
| Study Type | INTERVENTIONAL |
| Enrollment | 450 participants |
| Start Date | 2023-06-19 |
| Primary Completion | 2027-06-19 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 450 participants in total. It began in 2023-06-19 with a primary completion date of 2027-06-19.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Eligibility 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%
Contact & Investigator
Aksone Nouvong, DPM
PRINCIPAL INVESTIGATOR
University of California, Los Angeles
Frequently Asked Questions
Who can join the NCT05758545 clinical trial?
This trial is open to participants of all sexes, aged 22 Years or older, up to 90 Years, studying Diabetic Foot Ulcer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05758545 currently recruiting?
Yes, NCT05758545 is actively recruiting participants. Contact the research team at williams@piomic.com for enrollment information.
Where is the NCT05758545 trial being conducted?
This trial is being conducted at Mesa, United States, Tucson, United States, Castro Valley, United States, Fresno, United States and 11 additional locations.
Who is sponsoring the NCT05758545 clinical trial?
NCT05758545 is sponsored by Piomic Medical. The principal investigator is Aksone Nouvong, DPM at University of California, Los Angeles. The trial plans to enroll 450 participants.