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Procedure

COMS One Device for Diabetic Foot Ulcers (Mavericks Trial)

N/A
Recruiting
Led By Aksone Nouvong, DPM
Research Sponsored by Piomic Medical
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Subjects are male or female, ≥22 and ≤90 years of age
Type 1 or Type 2 diabetes mellitus
Must not have
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 currently undergoing treatment for an active systemic infection, including osteomyelitis
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 8 week, 12 week, 16 week, 20 week and 24 week

Summary

This trial tests the COMS One device, which helps heal tough wounds, on patients with hard-to-treat diabetic foot ulcers. The device encourages new skin growth and stops fluid leakage to promote healing.

Who is the study for?
This trial is for adults aged 22-90 with Type 1 or Type 2 diabetes and a diabetic foot ulcer lasting more than 30 days but less than a year, sized between 0.5 - 25 cm². Participants must have good blood flow in the affected limb and be willing to use contraception if of childbearing potential. Excluded are those with certain cancers, severe anemia, malnutrition, pregnancy, high BUN levels, recent other trial participation, active systemic infections like osteomyelitis, extreme neutropenia or renal insufficiency requiring dialysis.
What is being tested?
The COMS One device's ability to heal diabetic foot ulcers compared to a sham (fake) device is being tested over a period of twelve weeks. Both devices will be used alongside standard care treatments for these ulcers. The study randomly assigns participants to either the real or sham treatment without them knowing which one they're receiving (double-blinded).
What are the potential side effects?
Since this trial involves a medical device rather than medication, side effects may include local skin reactions at the site of application such as redness or irritation. There could also be discomfort associated with wearing the device.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 22 and 90 years old.
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I have diabetes (Type 1 or Type 2).
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I have a deep foot ulcer below my ankle.
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My wound is shallow and does not expose bone.
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My foot ulcer has lasted more than 30 days but less than a year.
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Blood flow in my limb with the wound is within a healthy range.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have or had skin cancer, precancerous skin conditions, or large moles in the treatment area.
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I am currently being treated for a serious infection.
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My wound is severe, affecting deep tissues or bone.
Select...
I am on dialysis for end-stage kidney disease.
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I have been on steroids like prednisone above 10mg/day for more than 10 days or any dose for over 30 days.
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My foot ulcer has healed by more than 30% in the last 2 weeks or more than 50% since my last visit.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~8 week, 12 week, 16 week, 20 week and 24 week
This trial's timeline: 3 weeks for screening, Varies for treatment, and 8 week, 12 week, 16 week, 20 week and 24 week for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Complete wound healing
Secondary study objectives
Incidence of all related or serious adverse events
Incidence of complete wound closure
Pain assessment
+6 more

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: COMS One deviceActive Control1 Intervention
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 COMS One device is reusable (the component can be used on multiple subjects and is cleaned between uses). 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.
Group II: Sham devicePlacebo Group1 Intervention
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 sham device is reusable (the component can be used on multiple subjects and is cleaned between uses). 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.

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for foot ulcers, particularly those similar to the COMS One device, work by promoting wound healing through mechanisms such as enhancing tissue regeneration, improving blood flow, and reducing infection. These treatments may stimulate cellular activity and collagen synthesis, which are essential for closing wounds effectively. For foot ulcer patients, especially those with diabetes, these mechanisms are vital as they help prevent complications like infections, reduce the risk of amputations, and improve overall quality of life.

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Who is running the clinical trial?

NAMSAOTHER
53 Previous Clinical Trials
20,563 Total Patients Enrolled
1 Trials studying Foot Ulcer
180 Patients Enrolled for Foot Ulcer
Piomic MedicalLead Sponsor
Aksone Nouvong, DPMPrincipal InvestigatorUniversity of California, Los Angeles
1 Previous Clinical Trials
256 Total Patients Enrolled
1 Trials studying Foot Ulcer
256 Patients Enrolled for Foot Ulcer

Media Library

COMS One device (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT05758545 — N/A
Foot Ulcer Research Study Groups: COMS One device, Sham device
Foot Ulcer Clinical Trial 2023: COMS One device Highlights & Side Effects. Trial Name: NCT05758545 — N/A
COMS One device (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05758545 — N/A
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