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

Medical Coherence LLC

Status: Terminated

Conditions: Diabetic Foot Ulcer

Treatments: Device: MC-8XL low level laser device and Standard wound care; Device: Sham laser device and Standard wound care

Study type: Interventional

Funder types: Industry

Identifiers

NCT03204149

BBL-0043-16

Details and patient eligibility

About

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.

Enrollment: 5 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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5 participants in 2 patient groups

Treatment group

Experimental group

Description:

The treatment group will be treated with the MC-8XL laser device, emitting 808 nm laser beam with a green laser beam. Intervention: MC-8XL low level laser device and Standard wound care

Treatment:

Device: MC-8XL low level laser device and Standard wound care

Control group

Sham Comparator group

Description:

The control group will receive treatment with a sham laser device, emitting a low power green light with inactive Infrared (IR) laser for indication only. Intervention: Sham laser device and Standard wound care

Treatment:

Device: Sham laser device and Standard wound care