Evaluation of Safety of Low Level Laser Device Treatment in Chronic Wounds

"The MC-8XL, a handheld Low Level Laser Therapy (LLLT) device, comprised of an infrared laser diode that generates wavelength of 808 nm and a green laser diode with a wavelength of 525 nm will be used to treat the experimental group.~Along with the active LLLT, generally accepted standard wound care procedures will be used during the clinical trial by a qualified study nurse or doctor. These procedures will include wound cleaning and drying before irradiation with the laser device (sham or active). Each ulcer will be also assessed and debrided if needed.~After irradiation, each ulcer will be dressed with saline gauze dressing and offloaded."

"The Sham device is of similar appearance, emitting only green light for indication with a wavelength of 525 nm of a low power, with inactive IR laser which will be used in the Control group.~Along with the sham device, the same generally accepted standard wound care procedures will be used."