Clinical trial NCT05758545: Trial to Evaluate the Safety and Effectiveness of Treatment With COMS One Device in Subjects With Diabetic Foot Ulcers
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Diabetic Foot Ulcer
Keywords: Refractory Diabetic Foot Ulcer (DFU)
Lead sponsor: Piomic Medical
Sponsor class: INDUSTRY
Collaborators: name: NAMSA
First posted: 2023-03-07
Enrollment: 450
Sex: ALL
Minimum age (years): 22
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model 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.

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.
Primary purpose: TREATMENT

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.

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%

Primary outcomes:
measure: Complete wound healing
timeFrame: 24 weeks post-application
Secondary outcomes:
measure: Time to ≥50% wound area reduction
timeFrame: Through 24 weeks
measure: Time to ≥90% wound area reduction
timeFrame: Through 24 weeks
measure: Incidence of complete wound closure
timeFrame: 8 week, 12 week, 16 week, 20 week and 24 week
measure: Partial wound closure
timeFrame: 8 week, 12 week, 16 week, 20 week and 24 week
measure: Incidence of all related or serious adverse events
timeFrame: Up to week 12 and week 24
measure: Time to target diabetic foot ulcer re-occurrence
timeFrame: Up to 24 weeks
measure: Time to amputation
timeFrame: Up to 24 weeks
measure: Pain assessment
timeFrame: Week 1, Week 8, Week 12, Week 24
measure: Quality of life survey
timeFrame: Week 1, Week 8, Week 12, Week 24
Other outcomes:
Locations:
city: Mesa
country: United States
facility: Titan Clinical Research
state: Arizona
city: Tucson
country: United States
facility: Southern Arizona VA Health Care System
state: Arizona
city: Castro Valley
country: United States
facility: Center for Clinical Research Inc.
state: California
city: Fresno
country: United States
facility: Limb Preservation Platform, Inc.
state: California
city: Los Angeles
country: United States
facility: Angel City Research, Inc.
state: California
city: Los Angeles
country: United States
facility: UCLA Ronald Regan - Department of Surgery
state: California
city: San Francisco
country: United States
facility: Center for Clinical Research Inc.
state: California
city: San Francisco
country: United States
facility: Center for Clinical Research Inc.
state: California
city: Vista
country: United States
facility: ILD Research Center
state: California
city: Bay Pines
country: United States
facility: Bay Pines VA Healthcare System
state: Florida
city: Jacksonville
country: United States
facility: University of Florida Health Jacksonville
state: Florida
city: Miami Lakes
country: United States
facility: The Angel Medical Research Corporation
state: Florida
city: Miami
country: United States
facility: Clever Medical Research LLC
state: Florida
city: Augusta
country: United States
facility: Aiyan Diabetes Center
state: Georgia
city: Chicago
country: United States
facility: Northwestern University Feinberg School of Medicine
state: Illinois
city: Chicago
country: United States
facility: Rush University
state: Illinois
city: O'Fallon
country: United States
facility: Gateway Clinical Trials
state: Illinois
city: Westwood
country: United States
facility: Curalta Clinical Trials
state: New Jersey
city: Buffalo
country: United States
facility: Veteran Affairs of WNY Healthcare System
state: New York
city: Lake Success
country: United States
facility: Northwell Comprehensive Wound Healing Center
state: New York
city: Chapel Hill
country: United States
facility: UNC Medical Center
state: North Carolina
city: Columbus
country: United States
facility: The Ohio State University
state: Ohio
city: McKeesport
country: United States
facility: UPMC McKeesport
state: Pennsylvania
city: Nashville
country: United States
facility: Vanderbilt University Medical Center - Vanderbilt Wound Center
state: Tennessee
city: Dallas
country: United States
facility: Richard C. Galperin DPM PA
state: Texas
city: Houston
country: United States
facility: HCA Healthcare Houston Medical Center
state: Texas
city: McAllen
country: United States
facility: Futuro Clinical Trials, LLC
state: Texas
Study officials:
affiliation: University of California, Los Angeles
name: Aksone Nouvong, DPM
role: PRINCIPAL_INVESTIGATOR
References: