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

Diabetic Foot Ulcer Clinical Trial

— Mavericks  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05758545
• Other study ID #: COMS_03
• Status: Recruiting
• Phase: N/A
• 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
• 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%

Related Conditions & MeSH terms

• Diabetic Foot
• Diabetic Foot Ulcer
• Foot Ulcer
• Ulcer

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