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

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.

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.