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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 8 week, 12 week, 16 week, 20 week and 24 week
Awards & highlights
Mavericks Trial Summary
This trial evaluates the safety and effectiveness of a device to treat diabetic foot ulcers, comparing it to a control device and standard of care.
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.Check my eligibility
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).See study design
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.
Mavericks Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
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.
Mavericks Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 8 week, 12 week, 16 week, 20 week and 24 week
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~8 week, 12 week, 16 week, 20 week and 24 week
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Complete wound healing
Secondary outcome measures
Incidence of all related or serious adverse events
Incidence of complete wound closure
Median time to 50% wound area reduction
+6 moreMavericks Trial Design
2Treatment groups
Active Control
Placebo Group
Group I: COMS One deviceActive Control1 Intervention
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.
Group II: Sham devicePlacebo Group1 Intervention
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.
Find a Location
Who is running the clinical trial?
NAMSAOTHER
45 Previous Clinical Trials
16,603 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
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been on steroids like prednisone above 10mg/day for more than 10 days or any dose for over 30 days.My foot ulcer has healed by more than 30% or 50% during the screening phase.I have or had skin cancer, precancerous skin conditions, or large moles in the treatment area.Your hemoglobin level is less than 8.0 grams per deciliter.I have a deep foot ulcer below my ankle.Your pre-albumin level is less than 10 mg/dL.Your blood urea nitrogen (BUN) level is higher than 60 mg/dL.I am using or willing to use birth control during the study.Your absolute neutrophil count is less than 1.0 x 10^9 per liter.I am not on medications that could affect my wound healing.I am currently being treated for a serious infection.I have diabetes (Type 1 or Type 2).My wound is severe, affecting deep tissues or bone.My wound is shallow and does not expose bone.I am on dialysis for end-stage kidney disease.My foot ulcer has healed by more than 30% in the last 2 weeks or more than 50% since my last visit.Your blood test results show certain levels that are outside of the normal range.Your HbA1C level is higher than 12%.My foot ulcer has lasted more than 30 days but less than a year.I am between 22 and 90 years old.My foot ulcer's size is between 0.5 and 25 cm2.Your white blood cell count is less than 2.0 x 10^9 per liter.Your platelet count is less than 50 billion per liter.Your blood creatinine level is higher than 4.0 mg/dL.My foot ulcer is at least 2 cm away from any other ulcer after cleaning.Blood flow in my limb with the wound is within a healthy range.
Research Study Groups:
This trial has the following groups:- Group 1: COMS One device
- Group 2: Sham device
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Who meets the eligibility criteria for participation in this research trial?
"Patients who suffer from foot ulcers and are between 22 to 90 years old can be eligible for this trial. The total number of participants accepted is 320 individuals."
Answered by AI
To what limit has the participation in this experiment been capped?
"This trial requires 320 qualified participants and is recruiting from multiple sites, such as San Francisco's Clever Medical Research LLC or Bay Pines VA Healthcare System in Miami. New york also has an eligible location for enrollment."
Answered by AI
Does this trial enroll individuals of more advanced age?
"This trial is recruiting individuals of advanced age, with a minimum age requirement of 22 and an upper limit set at 90."
Answered by AI
How widespread is the implementation of this experimental protocol?
"This trial is offering 7 different clinics for potential participants to join. These include Clever Medical Research LLC in San Francisco, Bay Pines VA Healthcare System in Miami, and The Angel Medical Research Corporation from Bay Pines. Furthermore, there are 4 additional facilities available across the country."
Answered by AI
Does this medical research currently have slots available for participants?
"Affirmative. According to information posted on clinicaltrials.gov, this research project is actively enrolling participants. It was announced in June 2019 and the most recent updates were published in August of 2023. The trial hopes to find 320 patients from 7 different medical locations."
Answered by AI
Who else is applying?
What site did they apply to?
Northwell Comprehensive Wound Healing Center
What portion of applicants met pre-screening criteria?
Met criteria
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