Trial to Evaluate the Safety and Effectiveness of Treatment With COMS One Device in Subjects With Diabetic Foot Ulcers
- Conditions
- Diabetic Foot Ulcer
- Interventions
- Device: COMS One deviceDevice: Sham device
- Registration Number
- NCT05758545
- Lead Sponsor
- Piomic Medical
- 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.
- 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 through 24 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 time to complete wound healing, 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 450 subjects with refractory DFU will be screened. It is expected that 50% of subjects will be excluded from the trial if either of the following occurs 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) to account for approximately 10% missing data due to early trial withdrawal or missed endpoint assessment.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 450
- 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
-
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%
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description COMS One device 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. Sham device 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.
- Primary Outcome Measures
Name Time Method Complete wound healing 24 weeks post-application The primary endpoint for this pivotal trial is time to complete wound closure from randomization through 24 weeks, which is defined as complete skin re-epithelialization without drainage confirmed by 2 consecutive trial visits 2 weeks apart.
- Secondary Outcome Measures
Name Time Method Partial wound closure 8 week, 12 week, 16 week, 20 week and 24 week Percent Wound Area Reduction (PWAR) at week 8, 12, 16, 20, 24
Incidence of complete wound closure 8 week, 12 week, 16 week, 20 week and 24 week Incidence of complete wound closure after 8, 12, 16, 20, and 24 weeks, which is defined as complete skin re-epithelialization without drainage
Time to ≥50% wound area reduction Through 24 weeks Time in number of days until wound area is reduced by ≥50% compared to wound area at time of randomization
Time to ≥90% wound area reduction Through 24 weeks Time in number of days until wound area is reduced by ≥90% compared to wound area at time of randomization
Incidence of all related or serious adverse events Up to week 12 and week 24 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.
Time to target diabetic foot ulcer re-occurrence 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
Time to amputation 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
Pain assessment 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
Quality of life survey 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
Trial Locations
- Locations (25)
Titan Clinical Research
🇺🇸Mesa, Arizona, United States
Southern Arizona VA Health Care System
🇺🇸Tucson, Arizona, United States
Center for Clinical Research Inc.
🇺🇸San Francisco, California, United States
Limb Preservation Platform, Inc.
🇺🇸Fresno, California, United States
Angel City Research, Inc.
🇺🇸Los Angeles, California, United States
UCLA Ronald Regan - Department of Surgery
🇺🇸Los Angeles, California, United States
ILD Research Center
🇺🇸Vista, California, United States
Bay Pines VA Healthcare System
🇺🇸Bay Pines, Florida, United States
University of Florida Health Jacksonville
🇺🇸Jacksonville, Florida, United States
The Angel Medical Research Corporation
🇺🇸Miami Lakes, Florida, United States
Clever Medical Research LLC
🇺🇸Miami, Florida, United States
Aiyan Diabetes Center
🇺🇸Augusta, Georgia, United States
Northwestern University Feinberg School of Medicine
🇺🇸Chicago, Illinois, United States
Rush University
🇺🇸Chicago, Illinois, United States
Gateway Clinical Trials
🇺🇸O'Fallon, Illinois, United States
Curalta Clinical Trials
🇺🇸Westwood, New Jersey, United States
Veteran Affairs of WNY Healthcare System
🇺🇸Buffalo, New York, United States
Northwell Comprehensive Wound Healing Center
🇺🇸Lake Success, New York, United States
UNC Medical Center
🇺🇸Chapel Hill, North Carolina, United States
The Ohio State University
🇺🇸Columbus, Ohio, United States
UPMC McKeesport
🇺🇸McKeesport, Pennsylvania, United States
Vanderbilt University Medical Center - Vanderbilt Wound Center
🇺🇸Nashville, Tennessee, United States
Richard C. Galperin DPM PA
🇺🇸Dallas, Texas, United States
HCA Healthcare Houston Medical Center
🇺🇸Houston, Texas, United States
Futuro Clinical Trials, LLC
🇺🇸McAllen, Texas, United States