COMS One Device for Diabetic Foot Ulcers

(Mavericks Trial)

Recruiting at 21 trial locations

Overseen By Janaki Nadarajah, DPM

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Piomic Medical

Must not be taking: Systemic corticosteroids

Disqualifiers: Pregnancy, Skin cancer, Systemic infection, Dialysis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 24

Duration: 24 weeks

450 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Do I have to stop taking my current medications for the trial?

The trial does not specify if you need to stop taking your current medications, but if you are on medications that the investigator believes may interfere with healing, you might need to stop them. It's best to discuss your specific medications with the trial team.

How is the COMS One Therapy System different from other treatments for diabetic foot ulcers?

The COMS One Therapy System is unique because it likely involves a novel approach, such as electrical stimulation, which is used to speed up wound healing in diabetic foot ulcers, offering a different mechanism compared to traditional treatments. ^{1 2 3 4 5}

What data supports the effectiveness of the COMS One treatment for diabetic foot ulcers?

The effectiveness of the COMS One treatment for diabetic foot ulcers might be supported by similar treatments like the Renasys-GO™ negative pressure wound therapy system, which has shown effectiveness in healing diabetic lower limb ulcers. Additionally, tissue engineered skin has been found to improve wound closure in diabetic foot ulcers, suggesting that advanced wound care systems can be beneficial. ^{6 7 8 9 10}

Who Is on the Research Team?

Aksone Nouvong, DPM

Principal Investigator

University of California, Los Angeles

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

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)

I have a deep foot ulcer below my ankle.

I am using or willing to use birth control during the study.

Exclusion 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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive treatment with the COMS One device or sham device in conjunction with standard of care for diabetic foot ulcers

24 weeks

Multiple visits throughout the 24 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, including wound healing and adverse events

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• COMS One device
• Sham device

Trial Overview 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).

How Is the Trial Designed?

Group I: COMS One device Active Control 1 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 device Placebo Group 1 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.

COMS One device is already approved in European Union, Switzerland for the following indications:

Approved in European Union as COMS One Therapy System for:

• Chronic leg and foot ulcers

Approved in Switzerland as COMS One Therapy System for:

• Hard-to-heal wounds
• Chronic leg and foot ulcers

Who Is Running the Clinical Trial?

Piomic Medical

Lead Sponsor

Trials

1

Recruited

450+

NAMSA

Collaborator

Trials

55

Recruited

21,500+

Published Research Related to This Trial

This study is testing a new in-shoe pressure measurement technology to create optimized insoles for people with diabetic neuropathy, aiming to reduce the risk of foot ulcers, with 76 participants recruited for a multicentre randomized controlled trial.

The trial will assess the feasibility of the new insoles compared to standard insoles over 12 months, focusing on recruitment, retention, and clinical outcomes like the incidence of foot ulcers and changes in peak plantar pressure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

INSoles To Ease Pressure (INSTEP) Study: a multicentre, randomised controlled feasibility study to compare the effectiveness of a novel instant optimised insole with a standard insole for people with diabetic neuropathy: a study protocol. Collings, R., Freeman, JA., Latour, J., et al.[2021]

Over a 10-year period, the healing rates for neuropathic toe ulcers increased significantly from 75% to 91%, and for neuro-ischemic toe ulcers from 72% to 80%, indicating improved treatment outcomes in patients with diabetic foot ulcers.

The overall healing rate for neuropathic and neuro-ischemic toe ulcers nearly doubled (HR=1.95) during the study, which correlated with enhancements in clinic organization and therapy rather than changes in patient characteristics.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Increased healing in diabetic toe ulcers in a multidisciplinary foot clinic-An observational cohort study. Almdal, T., Nielsen, AA., Nielsen, KE., et al.[2018]

A 58-year-old patient with a high-risk diabetic foot lesion was successfully treated using a new innovative wound environment control system, highlighting its potential effectiveness in preventing major amputations.

This case demonstrates the promising application of advanced wound care technology in managing complex diabetic foot conditions, which are often challenging to treat.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Wound Environment Control System to Avoid Major Amputation in Diabetic Foot Ulcers. Vouillarmet, J., Fribourg, G., Labaisse, L., et al.[2023]

A meta-analysis of 8 studies involving 1060 patients found that tissue engineered skin significantly improves wound closure in diabetic foot ulcers compared to conventional treatments, with an odds ratio of 1.76.

Subgroup analyses revealed that specific types of tissue engineered skin, such as Derma graft and Graft skin, showed even greater effectiveness, with odds ratios of 1.91 and 2.05, respectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tissue engineered skin for diabetic foot ulcers: a meta-analysis. Li, X., Xu, G., Chen, J.[2022]

In a case series of 10 patients with diabetic lower limb ulcers, the Renasys-GO™ negative pressure wound therapy system successfully healed all wounds, with an average treatment duration of 15.9 days.

The therapy not only reduced wound size and cleared bacterial infections but also promoted sufficient granulation tissue, enabling closure through either split-thickness skin grafting or secondary healing.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The role of Renasys-GO™ in the treatment of diabetic lower limb ulcers: a case series. Chan, SY., Wong, KL., Lim, JX., et al.[2020]

In a study of 33 patients with chronic diabetic foot ulcers, daily home-based electrical stimulation (E-Stim) therapy for 4 weeks resulted in a significant 22% reduction in wound area, demonstrating its effectiveness in promoting healing.

The high adherence rate of 93.9% to the E-Stim therapy suggests that it is a feasible and acceptable treatment option for patients with diabetic foot ulcers and peripheral arterial disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Home-Based Electrical Stimulation to Accelerate Wound Healing-A Double-Blinded Randomized Control Trial. Zulbaran-Rojas, A., Park, C., El-Refaei, N., et al.[2023]

The innovative intelligent insole system significantly reduced the incidence of diabetic foot ulcers by 71% over 18 months in high-risk patients compared to a control group, demonstrating its efficacy in preventing ulcer recurrence.

In patients who complied well with the system, the reduction in ulcer incidence was even greater at 86%, highlighting the potential of continuous plantar pressure monitoring and dynamic offloading guidance in managing diabetic foot health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Innovative intelligent insole system reduces diabetic foot ulcer recurrence at plantar sites: a prospective, randomised, proof-of-concept study. Abbott, CA., Chatwin, KE., Foden, P., et al.[2021]

The SmartBoot, a smart offloading device for diabetic foot ulcers, demonstrated high accuracy in monitoring patient adherence with an average accuracy of 89.3%, which is crucial for effective healing.

Participants showed improved balance while using the SmartBoot, suggesting that it provides beneficial somatosensory feedback, and most users found it comfortable and easy to use, indicating its potential for clinical application.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Smart Offloading Boot System for Remote Patient Monitoring: Toward Adherence Reinforcement and Proper Physical Activity Prescription for Diabetic Foot Ulcer Patients. Park, C., Mishra, R., Vigano, D., et al.[2023]

Diabetic foot disease, characterized by neuropathic ulcers, poses a significant risk of amputation for diabetic patients due to complex vascular damage and nerve issues.

Regular foot examinations and pressure measurements by diabetologists are crucial for prevention, and the new Dynamic System instrument can enhance the accuracy of foot pressure assessments in these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Usefulness of plantar pressure measurement for the prevention and treatment of neuropathic diabetic foot]. Scionti, L., Marino, C., Porcellati, F., et al.[2006]

The KADAM topical warm oxygen therapy device significantly improved healing in diabetic foot ulcers (DFUs), with 100% wound size reduction in Grade 1 and 2 ulcers, and a 75% reduction in Grade 3 ulcers among 40 participants.

This therapy delivers pure oxygen at a concentration of 93% and a temperature of 39-42º Celsius, demonstrating its potential as an effective adjunctive treatment for DFUs in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

KADAM topical warm oxygen therapy device for diabetic foot ulcer-a novel approach. Maiya, GA., Nataraj, M., K, G., et al.[2023]

Citations

1. England pubmed.ncbi.nlm.nih.gov

INSoles To Ease Pressure (INSTEP) Study: a multicentre, randomised controlled feasibility study to compare the effectiveness of a novel instant optimised insole with a standard insole for people with diabetic neuropathy: a study protocol. [2021]

2. Ireland pubmed.ncbi.nlm.nih.gov

Increased healing in diabetic toe ulcers in a multidisciplinary foot clinic-An observational cohort study. [2018]

3. Switzerland pubmed.ncbi.nlm.nih.gov

A Wound Environment Control System to Avoid Major Amputation in Diabetic Foot Ulcers. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Tissue engineered skin for diabetic foot ulcers: a meta-analysis. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

The role of Renasys-GO™ in the treatment of diabetic lower limb ulcers: a case series. [2020]

6. United States pubmed.ncbi.nlm.nih.gov

Home-Based Electrical Stimulation to Accelerate Wound Healing-A Double-Blinded Randomized Control Trial. [2023]

7. England pubmed.ncbi.nlm.nih.gov

Innovative intelligent insole system reduces diabetic foot ulcer recurrence at plantar sites: a prospective, randomised, proof-of-concept study. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Smart Offloading Boot System for Remote Patient Monitoring: Toward Adherence Reinforcement and Proper Physical Activity Prescription for Diabetic Foot Ulcer Patients. [2023]

9. Italy pubmed.ncbi.nlm.nih.gov

[Usefulness of plantar pressure measurement for the prevention and treatment of neuropathic diabetic foot]. [2006]

10. Switzerland pubmed.ncbi.nlm.nih.gov

KADAM topical warm oxygen therapy device for diabetic foot ulcer-a novel approach. [2023]