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

Evaluation of Safety of Low Level Laser MC-8XL Device Treatment in Chronic Wounds

This is a randomized, double blind, placebo-controlled study to evaluate the safety of the low level laser MC-8XL device treatment in subjects with an unsuccessfully treated Diabetic Foot Ulcer (DFU) that has been present for at least 3 months.

Eligible subjects will be randomized to either Treatment group or Control group, following which, treatment of each subject will be provided by a qualified nurse at the clinic or in the home setting, everyday for up to 16 weeks.

Study assessments and adverse events monitoring will be also performed throughout the study.

Inclusion Criteria:

• Provide signed and dated Informed Consent Form
• Willing to comply with all study procedures and be available for the duration of the study
• Male or female, aged 18 to 90
• Having a DFU of at least 3 months duration that had not improved after prior standard wound treatments
• HbA1c of <11.0
• Size of wounds: 1-10 cm2
• Having DFU of grades 2 or 3 according to Wagner's classification

Exclusion Criteria:

• Immeasurable wounds or wounds that are unsuited to this laser treatment (usually due to the wound's location, e.g. in the area between the toes).
• Uncontrolled Diabetes defined as an HbA1c of > 11.0
• Arterial insufficiency, Doppler vascular assessment (if needed- Ankle Brachial Index (ABI) < 0.6)
• Osteomyelitis in the bone.
• Photosensitivity
• Pregnancy
• Presence of any suspicious pre-cancerous or cancerous lesions, or having cancer.
• Being on medications that are immunosuppressive, may affect peripheral blood flow or may affect normal wound healing.
• Being on medications that might cause photosensitivity.
• Participation in any other clinical trial testing a device or drug.