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

• ClinicalTrials.gov Identifier: NCT05758545
• Recruitment Status: Recruiting
• First Posted: March 7, 2023
• Last Update Posted: August 9, 2023
• Sponsor: Piomic Medical
• Collaborator: NAMSA
• Information provided by (Responsible Party): Piomic Medical

Study Description

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

Condition or disease	Intervention/treatment	Phase
Diabetic Foot Ulcer	Device: COMS One device; Device: Sham device	Not Applicable

Detailed 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).

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 320 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment

Intervention Model Description

The purpose of this clinical trial is to evaluate the safety and effectiveness of treatment with the COMS One device in subjects with refractory DFUs. The randomized, sham-controlled, double-blinded 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 SOC, in the treatment of DFUs.

Following randomization, subjects will be assigned treatment with either COMS One device or the Sham device in conjunction with SOC. At least 50% of subjects are required to be 65 years or older at randomization.

Prospective, randomized, double-blinded, placebo-controlled trials provide the most objective methods for analyzing the outcomes of multiple treatment groups. The blinded use of a sham device allows for a true comparison of COMS One treatment in conjunction with SOC to SOC alone.

• Masking: Double (Participant, Investigator)

Masking Description

Permuted block randomization across all sites will be applied to generate randomization codes. Both the COMS One device and the Sham device will be prepared to appear to be identical to the subject to achieve the double-blind purposes and each device will be given a unique serial identifier.

To avoid assessment bias, each site will have an Inter-observer (blinded assessor) who will be blinded to treatment and perform and document all assessments of the target DFU evolution. Following target DFU assessment, the treatment will be performed by another assigned clinician, who will not have any involvement with the Inter-observer. This will provide an adequate level of masking to ensure that the trial is double-blinded.

• Primary Purpose: Treatment
• Official Title: Concurrent Optical and Magnetic Stimulation (COMS) for Treatment of Refractory Diabetic Foot Ulcer; a Prospective Randomized, Sham-controlled, Double-blinded, Pivotal Clinical Trial
• Actual Study Start Date: June 19, 2023
• Estimated Primary Completion Date: June 19, 2025
• Estimated Study Completion Date: June 19, 2025

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: COMS One device; The COMS One device is reusable (the component can be used on multiple subjects and is cleaned between uses). The COMS One device is the housing unit for the user controls, displays and functions including embedded software, lithium-ion battery, optical (LEDs) and a magnetic stimulation coil. The COMStouch is a sterile single-use component. The COMStouch provides a base and sterile barrier for the COMS One device. The COMSfix component is a self-adhesive single-use strap used to hold the COMS One device and COMStouch components in place during treatment.	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.; Other Name: Concurrent Optical and Magnetic Stimulation
Sham Comparator: Sham device; The sham device is reusable (the component can be used on multiple subjects and is cleaned between uses). The sham device is the housing unit for the user controls, displays and functions including embedded software, lithium-ion battery, optical (LEDs) and a magnetic stimulation coil. The COMStouch is a sterile single-use component. The COMStouch provides a base and sterile barrier for the sham device. The COMSfix component is a self-adhesive single-use strap used to hold the sham device and COMStouch components in place during treatment.	Device: 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.

Outcome Measures

Primary Outcome Measures :

1. Complete wound healing [ Time Frame: 12 weeks post application ]
   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.

Secondary Outcome Measures :

1. Median time to 50% wound area reduction [ Time Frame: 24 weeks ]
   Time in number of days until wound area is reduced by 50% compared to wound area at time of randomization
2. Median time to 90% wound area reduction [ Time Frame: 24 weeks ]
   Time in number of days until wound area is reduced by 90% compared to wound area at time of randomization
3. Incidence of complete wound closure [ Time Frame: 8 week, 16 week, 20 week and 24 week ]
   Incidence of complete wound closure after 8, 16, 20, and 24 weeks, which is defined as complete skin re-epithelialization without drainage
4. Partial wound closure [ Time Frame: 8 week, 12 week, 16 week, 20 week and 24 week ]
   Percent Wound Area Reduction (PWAR) at week 8, 12, 16, 20, 24
5. Incidence of all related or serious adverse events [ Time Frame: 24 weeks ]
   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.
6. Time to target diabetic foot ulcer re-occurrence [ Time Frame: Up to 24 weeks ]
   Time in number of days from randomization until re-occurrence of the target diabetic foot ulcer, assessed up to 24 weeks
7. Time to amputation [ Time Frame: Up to 24 weeks ]
   Time in number of days from randomization until amputation associated with the target diabetic foot ulcer, assessed up to 24 weeks
8. Pain assessment [ Time Frame: Week 1, Week 8, Week 12, Week 24 ]
   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
9. Quality of life survey [ Time Frame: Week 1, Week 8, Week 12, Week 24 ]
   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

Eligibility Criteria

• Ages Eligible for Study: 22 Years to 90 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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. 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%

Contacts and Locations

Contacts

Contact: Rejelle Williams; +41 44 244 19 78; williams@piomic.com

Contact: Bernard Laurel; +1-855-574-6642; laurel@piomic.com

Locations

United States, California

Center for Clinical Research Inc.; Recruiting

Castro Valley, California, United States, 94546

Contact: Maria Peralta 800-363-1069 ext 107 Maria@ccr-trials.com

Principal Investigator: Alexander Reyzelman, DPM

Center for Clinical Research Inc.; Recruiting

San Francisco, California, United States, 94115

Contact: Maria Paralta 800-363-1069 ext 107 Maria@ccr-trials.com

Principal Investigator: Alexander Reyzelman, DPM

Center for Clinical Research Inc.; Recruiting

San Francisco, California, United States, 94117

Contact: Maria Peralta 800-363-1069 ext 107 Maria@ccr-trials.com

Principal Investigator: Alexander Reyzelman, DPM

United States, Florida

Bay Pines VA Healthcare System; Not yet recruiting

Bay Pines, Florida, United States, 33744

Contact: Cortny Withee 727-398-6661 ext 15900 Cortny.withee@va.gov

Principal Investigator: Melissa Abercrombie, DMP

The Angel Medical Research Corporation; Recruiting

Miami Lakes, Florida, United States, 33016

Contact: Mari Garcia 786-542-5820 MGarcia@theangelresearch.com

Contact: Angel Achong +1-786-542-5820 Achong@theangelresearch.com

Principal Investigator: Jose L. Garcia, MD

Clever Medical Research LLC; Recruiting

Miami, Florida, United States, 33126

Contact: Margarita Hernandez 305-648-6381 mhernandez@clevermedresearch.com

Contact: Victor Hernandez +1-305-648-6381 vhernandez@clevermedresearch.com

Principal Investigator: Heliodoro Ruiz, MD

United States, New York

Northwell Comprehensive Wound Healing Center; Not yet recruiting

Lake Success, New York, United States, 11042

Contact: Sally Kaplan, RN 516-233-3780 Skaplan2@northwell.edu

Principal Investigator: Alisha Oropallo, MD

United States, Texas

Richard C. Galperin DPM PA; Recruiting

Dallas, Texas, United States, 75208

Contact: Tonya Hughes 214-330-9299 tonya.hughes5000@gmail.com

Principal Investigator: Richard C. Galperin, DPM

Sponsors and Collaborators

Piomic Medical

NAMSA

Investigators

• Principal Investigator: Aksone Nouvong, DPM; University of California, Los Angeles

More Information

• Responsible Party: Piomic Medical
• ClinicalTrials.gov Identifier: NCT05758545
• Other Study ID Numbers: COMS_03
• First Posted: March 7, 2023
• Last Update Posted: August 9, 2023
• Last Verified: August 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Device Product Not Approved or Cleared by U.S. FDA: Yes

Keywords provided by Piomic Medical:

Refractory Diabetic Foot Ulcer (DFU)

Additional relevant MeSH terms:

Diabetic Foot; Foot Ulcer; Ulcer; Pathologic Processes; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Leg Ulcer; Skin Ulcer; Skin Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies; Foot Diseases