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.
Subjects are male or female, ≥22 and ≤90 years of age
Female subjects of childbearing potential must be willing to use acceptable methods of contraception (birth control pills, barriers, or abstinence) starting at screening and throughout the duration of their study participation.
The participant (or LAR if applicable) must be 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)
Type 1 or Type 2 diabetes mellitus
Known pregnancy or lactating
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 taking any medications the Investigator believes may interfere with healing of the target DFU
Subject who is currently undergoing treatment for an active systemic infection, including osteomyelitis
Parallel
COMS One device
DeviceThe 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
DeviceThe 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.
Complete wound healing
The primary endpoint for this pivotal trial is time to complete wound closure from randomization through 24 weeks, which is defined as complete skin re-epithelialization without drainage confirmed by 2 consecutive trial visits 2 weeks apart.
Time to ≥50% wound area reduction
Time in number of days until wound area is reduced by ≥50% compared to wound area at time of randomization
Time to ≥90% wound area reduction
Time in number of days until wound area is reduced by ≥90% compared to wound area at time of randomization
Incidence of complete wound closure
Incidence of complete wound closure after 8, 12, 16, 20, and 24 weeks, which is defined as complete skin re-epithelialization without drainage
Partial wound closure
Percent Wound Area Reduction (PWAR) at week 8, 12, 16, 20, 24
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Piomic Medical
Lead sponsor
NAMSA
Collaborator
