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Trial to Evaluate the Safety and Effectiveness of Treatment With COMS One Device in Subjects With Diabetic Foot Ulcers

NCT05758545 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 450

Last updated 2026-02-17

No results posted yet for this study

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.

Conditions

  • Diabetic Foot Ulcer

Interventions

DEVICE

Sham device

The Sham device is a lightweight, portable device. The device is applied via a single use disposable component (COMStouch) that provides a base and sterile barrier for the unit. The device is attached via a single use strap (COMSfix). The device has been slightly adapted in order to make sure blinding is achieved/maintained. The specific features that have been modified for the purposes of blinding include the following: 1) therapeutic output, and 2) sensor detecting whether the device is lying on the skin.

DEVICE

COMS One device

The COMS One device incorporates technologies for optical and magnetic stimulation. The optical stimulation component is designed to emit light by two types of light emitting diodes (LEDs) in the wavelength of 660 nm (red) and 830 nm (near infrared) range of the electromagnetic spectra. The magnetic stimulation component is generated by a coil emitting pulse modulated magnetic fields in the extremely low frequency (ELF) range of the electromagnetic spectra. The COMS One is a lightweight, portable device. The device is locally applied via a single use disposable component (COMStouch) that provides a base and sterile barrier for the unit. The device is attached via a single use strap (COMSfix). The device has been slightly adapted in order to make sure blinding is achieved/maintained. The specific feature that has been modified for the purpose of blinding is sensor detecting whether the device is lying on the skin.

Sponsors & Collaborators

  • NAMSA

    collaborator OTHER

  • Piomic Medical

    lead INDUSTRY

Principal Investigators

  • Aksone Nouvong, DPM · University of California, Los Angeles

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
22 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-06-19
Primary Completion
2027-06-19
Completion
2027-06-19
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05758545 on ClinicalTrials.gov