What side effects are associated with this type of intervention?

Common treatments for diabetic foot ulcers that promote wound healing include advanced wound dressings, negative pressure wound therapy (NPWT), and hyperbaric oxygen therapy (HBOT). Advanced wound dressings, such as hydrocolloids and alginates, are generally well-tolerated but can sometimes cause skin irritation or allergic reactions. NPWT can lead to complications like pain, bleeding, and infection at the wound site. HBOT is associated with side effects such as ear and sinus pain, temporary vision changes, and, in rare cases, oxygen toxicity. The COMS One device, being studied for its effectiveness in wound healing, may have similar side effects related to skin irritation or localized infection, but specific data on its side effects are not yet available.

What prior FDA approvals exist?

The FDA has approved several treatments for diabetic foot ulcers that promote wound healing. These include advanced wound care products like Apligraf and Dermagraft, which are bioengineered skin substitutes that help in tissue regeneration. Additionally, Regranex (becaplermin) gel, a recombinant human platelet-derived growth factor, has been approved to promote the healing of diabetic neuropathic ulcers. These treatments, similar to the COMS One device, aim to enhance wound closure and improve healing outcomes in patients with diabetic foot ulcers.

What other types of research exist?

Promising novel alternatives to the COMS One device for treating diabetic foot ulcers include: <ol> <li>Negative Pressure Wound Therapy (NPWT) - This method uses a vacuum dressing to promote healing in acute or chronic wounds.</li> <li></li> </ol> Stem Cell Therapy - Utilizing stem cells to regenerate damaged tissues and promote healing. 3. Platelet-Rich Plasma (PRP) - Involves using a concentration of a patient's own platelets to accelerate the healing of injured tendons, ligaments, muscles, and joints. 4. Hyperbaric Oxygen Therapy (HBOT) - Involves breathing pure oxygen in a pressurized room or chamber to enhance the body's natural healing processes. 5. Bioengineered Skin Substitutes - Such as Apligraf and Dermagraft, which are designed to mimic the properties of human skin and promote wound healing.

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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.

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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 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

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

Median time to 50% wound area reduction

+6 more

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.

0 / 12Eligibility criteria met

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.