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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03204149
Recruitment Status : Terminated (Project termination)
First Posted : June 29, 2017
Last Update Posted : September 9, 2020
Sponsor:
Information provided by (Responsible Party):
Medical Coherence LLC

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.


Condition or disease Intervention/treatment Phase
Diabetic Foot Ulcer Device: MC-8XL low level laser device and Standard wound care Device: Sham laser device and Standard wound care Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Other
Official Title: Evaluation of Safety of Low Level Laser MC-8XL Device Treatment in Chronic Wounds
Actual Study Start Date : June 14, 2017
Actual Primary Completion Date : June 14, 2018
Actual Study Completion Date : June 14, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Treatment group

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

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.


Sham Comparator: Control group

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

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.





Primary Outcome Measures :
  1. Safety [ Time Frame: On a weekly basis until the end of the 16 week treatment period ]
    assessing device related and general adverse events


Secondary Outcome Measures :
  1. Wound Healing [ Time Frame: On a weekly basis until the end of the 16 week treatment period or until complete wound closure ]
    Percent of wounds achieving complete wound closure, wound granulation and percent change in ulcer size/area



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03204149


Locations
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Israel
Northern District Trauma & Wound Clinics Division, Maccabi Health Care Services
Haifa, Israel
Sponsors and Collaborators
Medical Coherence LLC
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Responsible Party: Medical Coherence LLC
ClinicalTrials.gov Identifier: NCT03204149    
Other Study ID Numbers: BBL-0043-16
First Posted: June 29, 2017    Key Record Dates
Last Update Posted: September 9, 2020
Last Verified: September 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetic Foot
Foot Ulcer
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Leg Ulcer
Skin Ulcer
Skin Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Diabetic Neuropathies
Foot Diseases