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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05758545
Other study ID # COMS_03
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date June 19, 2023
Est. completion date June 19, 2025

Study information

Verified date May 2024
Source Piomic Medical
Contact Rejelle Williams
Phone +41 44 244 19 78
Email williams@piomic.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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 at 12 weeks post-application, when each is administered in conjunction with standard of care (SOC) in the treatment of DFUs.


Description:

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 at 12 weeks post-application, when each is administered in conjunction with standard of care (SOC) in the treatment of DFUs. Primary Objective The COMS One Therapy System is intended to promote wound healing in chronic DFUs. As part of the clinical investigation, the primary objective is to determine complete wound healing at 12 weeks post-application of the device defined as complete skin re-epithelialization without drainage confirmed by 2 consecutive trial visits 2 weeks apart. Secondary Objectives Secondary objectives are confirmation of safety and assessment of wound healing parameters as well as subject and site reported outcomes. A total of 320 subjects with refractory DFU will be screened. It is expected that 30% of subjects will be excluded from the trial if either of the following occur between screening and randomization: >30% wound closure over a period of 2 weeks or >50% wound closure over a period of 4 weeks (measured post-debridement). The remaining 224 subjects will be randomized into two groups (112 Subjects Sham device treated; 112 Subjects Coms One device treated).


Recruitment information / eligibility

Status Recruiting
Enrollment 320
Est. completion date June 19, 2025
Est. primary completion date June 19, 2025
Accepts healthy volunteers No
Gender All
Age group 22 Years to 90 Years
Eligibility 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. 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 0.7 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 Principal Investigator (PI) 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 (such as history of HIV or a clinically significant cardiac, gastrointestinal, endocrine, neurological, liver, or kidney disease) 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 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%

Study Design


Related Conditions & MeSH terms


Intervention

Device:
COMS One device
The COMS One device incorporates technologies for optical and magnetic stimulation. The optical stimulation component is designed to emit light by two types of light emitting diodes (LEDs) in the wavelength of 660 nm (red) and 830 nm (near infrared) range of the electromagnetic spectra. The magnetic stimulation component is generated by a coil emitting pulse modulated magnetic fields in the extremely low frequency (ELF) range of the electromagnetic spectra. The System is a lightweight, portable device. The device is applied via a single use disposable component (COMStouch) that provides a base and sterile barrier for the unit. The device is attached via a single use strap (COMSfix). The device has been slightly adapted in order to make sure blinding is achieved/maintained. The specific feature that has been modified for the purposes of blinding is sensor detecting whether the device is lying on the skin.
Sham device
The Sham device is a lightweight, portable device. The device is applied via a single use disposable component (COMStouch) that provides a base and sterile barrier for the unit. The device is attached via a single use strap (COMSfix). The device has been slightly adapted in order to make sure blinding is achieved/maintained. The specific features that have been modified for the purposes of blinding include the following: 1) therapeutic output, and 2) sensor detecting whether the device is lying on the skin.

Locations

Country Name City State
United States Aiyan Diabetes Center Augusta Georgia
United States Bay Pines VA Healthcare System Bay Pines Florida
United States Center for Clinical Research Inc. Castro Valley California
United States UNC Medical Center Chapel Hill North Carolina
United States Northwestern University Feinberg School of Medicine Chicago Illinois
United States Rush University Chicago Illinois
United States The Ohio State University Columbus Ohio
United States Richard C. Galperin DPM PA Dallas Texas
United States HCA Healthcare Houston Medical Center Houston Texas
United States University of Florida Health Jacksonville Jacksonville Florida
United States Northwell Comprehensive Wound Healing Center Lake Success New York
United States UCLA Ronald Regan - Department of Surgery Los Angeles California
United States Clever Medical Research LLC Miami Florida
United States The Angel Medical Research Corporation Miami Lakes Florida
United States Vanderbilt University Medical Center - Vanderbilt Wound Center Nashville Tennessee
United States Center for Clinical Research Inc. San Francisco California
United States Center for Clinical Research Inc. San Francisco California

Sponsors (2)

Lead Sponsor Collaborator
Piomic Medical NAMSA

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Complete wound healing The primary endpoint for this pivotal trial is complete wound closure after 12 weeks of treatment, which is defined as complete skin re-epithelialization without drainage confirmed by 2 consecutive trial visits 2 weeks apart. 12 weeks post application
Secondary Median time to 50% wound area reduction Time in number of days until wound area is reduced by 50% compared to wound area at time of randomization 24 weeks
Secondary Median time to 90% wound area reduction Time in number of days until wound area is reduced by 90% compared to wound area at time of randomization 24 weeks
Secondary Incidence of complete wound closure Incidence of complete wound closure after 8, 16, 20, and 24 weeks, which is defined as complete skin re-epithelialization without drainage 8 week, 16 week, 20 week and 24 week
Secondary Partial wound closure Percent Wound Area Reduction (PWAR) at week 8, 12, 16, 20, 24 8 week, 12 week, 16 week, 20 week and 24 week
Secondary Incidence of all related or serious adverse events Number of subjects with one or more related adverse event or serious adverse events Related adverse events are those judged by the investigator to be possibly, probably, or definitely related to the COMS One device or other trial procedures. 24 weeks
Secondary Time to target diabetic foot ulcer re-occurrence Time in number of days from randomization until re-occurrence of the target diabetic foot ulcer, assessed up to 24 weeks Up to 24 weeks
Secondary Time to amputation Time in number of days from randomization until amputation associated with the target diabetic foot ulcer, assessed up to 24 weeks Up to 24 weeks
Secondary Pain assessment Wong-Baker FACES Pain Rating Scale - patient chooses the face that best demonstrates the physical pain they are experiencing at four time points throughout study participation Week 1, Week 8, Week 12, Week 24
Secondary Quality of life survey 36-Item Short Form Survey (SF-36) - health-related quality of life questionnaire that is completed by patients at four time points throughout study participation Week 1, Week 8, Week 12, Week 24
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