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

Conditions

• Diabetic Foot Ulcer

Eligibility Criteria

Sex

ALL

Age

22 Years - 90 Years

Healthy Volunteers

Not accepted

Interventions

• COMS One device — 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.
• Sham device — 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.

Study Details

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.

Key Dates

Start date

Jun 19, 2023

Status verified

Feb 2026

Primary completion

Jun 19, 2027

Completion

Jun 19, 2027

Study Design

Enrollment

450 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: COMS One device
  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.
• Sham Comparator: Sham device
  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.

Primary Outcome Measure

Complete wound healing [ Time Frame: 24 weeks post-application ]

Central Contacts

• Rejelle Williams
  +41 44 244 19 78
  [email protected]
• Bernard Laurel
  +1-855-574-6642
  [email protected]

Locations (30)

Find similar trials in Mesa, AZ

Related Studies

• Non-Invasive Testing to Evaluate Wound Healing in Diabetes
  Recruiting · University of Texas Southwestern Medical Center · Dallas, Texas
• Smart Boot Use to Measure Offloading Adherence
  PHASE2 · Recruiting · University of Southern California · Downey, California
• Real World Evidence with the Debritom+ TM Novel Micro Water Jet Technology At a Single Wound Center
  Recruiting · Medaxis, LLC · Bradenton, Florida
• A Clinical Investigation to Follow the Progress of Exuding Chronic Wounds Using Mepilex® Up as the Primary Dressing.
  Recruiting · Molnlycke Health Care AB · Castro Valley, California