Back to resultsEvaluation of Safety of Low Level Laser Device Treatment in Chronic Wounds
Primary Purpose
Diabetic Foot Ulcer
Status
Terminated
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
MC-8XL low level laser device and Standard wound care
Sham laser device and Standard wound care
Sponsored by
About this trial
This is an interventional other trial for Diabetic Foot Ulcer
Eligibility 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.
Sites / Locations
- Northern District Trauma & Wound Clinics Division, Maccabi Health Care Services
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Treatment group
Control group
Arm 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
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
Outcomes
Primary Outcome Measures
Safety
assessing device related and general adverse events
Secondary Outcome Measures
Wound Healing
Percent of wounds achieving complete wound closure, wound granulation and percent change in ulcer size/area
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03204149
Brief Title
Evaluation of Safety of Low Level Laser Device Treatment in Chronic Wounds
Official Title
Evaluation of Safety of Low Level Laser MC-8XL Device Treatment in Chronic Wounds
Study Type
Interventional
2. Study Status
Record Verification Date
September 2020
Overall Recruitment Status
Terminated
Why Stopped
Project termination
Study Start Date
June 14, 2017 (Actual)
Primary Completion Date
June 14, 2018 (Actual)
Study Completion Date
June 14, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medical Coherence LLC
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Foot Ulcer
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
5 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment group
Arm Type
Experimental
Arm 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
Arm Title
Control group
Arm Type
Sham Comparator
Arm 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
Intervention Type
Device
Intervention Name(s)
MC-8XL low level laser device and Standard wound care
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Sham laser device and Standard wound care
Intervention Description
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 Measure Information:
Title
Safety
Description
assessing device related and general adverse events
Time Frame
On a weekly basis until the end of the 16 week treatment period
Secondary Outcome Measure Information:
Title
Wound Healing
Description
Percent of wounds achieving complete wound closure, wound granulation and percent change in ulcer size/area
Time Frame
On a weekly basis until the end of the 16 week treatment period or until complete wound closure
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Northern District Trauma & Wound Clinics Division, Maccabi Health Care Services
City
Haifa
Country
Israel
12. IPD Sharing Statement
Learn more about this trial
Evaluation of Safety of Low Level Laser Device Treatment in Chronic Wounds
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