Evaluation of Safety of Low Level Laser Device Treatment in Chronic Wounds
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|ClinicalTrials.gov Identifier: NCT03204149|
Recruitment Status : Terminated (Project termination)
First Posted : June 29, 2017
Last Update Posted : September 9, 2020
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|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||5 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|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|
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.
- Safety [ Time Frame: On a weekly basis until the end of the 16 week treatment period ]assessing device related and general adverse events
- 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
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
|Northern District Trauma & Wound Clinics Division, Maccabi Health Care Services|