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

NCT03204149 | Terminated

• 1 other identifier: BBL-0043-16
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Diabetic Foot Ulcer

Outcome Measures

Primary Outcomes (1)

• Safety

  assessing device related and general adverse events

  On a weekly basis until the end of the 16 week treatment period

Secondary Outcomes (1)

• Wound Healing

  On a weekly basis until the end of the 16 week treatment period or until complete wound closure

Study Arms (2)

Treatment group

EXPERIMENTAL

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

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

Control group

SHAM COMPARATOR

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

Device: Sham laser device and Standard wound care

Interventions

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

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.

Treatment group

Sham laser device and Standard wound care DEVICE

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.

Control group

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medical Coherence LLC: lead

Study Sites (1)

Northern District Trauma & Wound Clinics Division, Maccabi Health Care Services

Haifa, Israel

Location

MeSH Terms

Conditions

Diabetic Foot

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 25, 2017
• First Posted: June 29, 2017
• Study Start: June 14, 2017
• Primary Completion: June 14, 2018
• Study Completion: June 14, 2019
• Last Updated: September 9, 2020

Record last verified: 2020-09

Locations

IL (1)