Diabetic Foot UlcerNCT03204149
Evaluation of Safety of Low Level Laser Device Treatment in Chronic Wounds
A study testing MC-8XL low level laser device and Standard wound care in people with Diabetic Foot Ulcer, run by Medical Coherence LLC at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Diabetic Foot Ulcer
- What is being tested?
- MC-8XL low level laser device and Standard wound care
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 5 participants
- Where
- 1 siteIsrael
- Study dates
- 14 Jun 2017to 14 Jun 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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 locations and contacts
1 site in 1 country.
Israel1 site
Northern District Trauma & Wound Clinics Division, Maccabi Health Care Services
Haifa
About this study
Official title: Evaluation of Safety of Low Level Laser MC-8XL Device Treatment in Chronic Wounds
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
- Being tested
- MC-8XL low level laser device and Standard wound care, Sham laser device and Standard wound care
- Medical subject headings
- Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MC-8XL low level laser device and Standard wound careDevice
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 laser device and Standard wound careDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Device: Sham laser device and Standard wound care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety
assessing device related and general adverse events
Measured: On a weekly basis until the end of the 16 week treatment period
Secondary outcomes (1)
Wound Healing
Percent of wounds achieving complete wound closure, wound granulation and percent change in ulcer size/area
Measured: On a weekly basis until the end of the 16 week treatment period or until complete wound closure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2017
- Study start14 Jun 2017
- Primary completion14 Jun 2018
- Study completion14 Jun 2019
Why it stopped: Project termination
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Foot UlcerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical Coherence LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03204149
- Sponsor's protocol ID
- BBL-0043-16
- Status last verified
- Sep 2020
- First submitted
- 25 Jun 2017
- Last updated
- 9 Sep 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Safety of Low Level Laser MC-8XL Device Treatment in Chronic Wounds
- ClinicalTrials.gov ID
- NCT03204149
- Acronym / sponsor ID
- BBL-0043-16
- Conditions
- Diabetic Foot Ulcer
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Project termination
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Medical Coherence LLCIndustry (pharma, biotech, devices)
- Study start
- 14 Jun 2017 (actual)
- Primary completion
- 14 Jun 2018 (actual)
- Study completion
- 14 Jun 2019 (actual)
- First posted
- 29 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Experimental | Device: MC-8XL low level laser device and Standard wound careThe 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 |
| Control group | Sham comparator | Device: Sham laser device and Standard wound careThe 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 |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MC-8XL low level laser device and Standard wound careThe 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. | Device | Treatment group |
| Sham laser device and Standard wound careThe 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. | Device | Control group |
Primary outcome
Safety
Time frame: On a weekly basis until the end of the 16 week treatment period
assessing device related and general adverse events
1 secondary outcome
Wound Healing
Time frame: On a weekly basis until the end of the 16 week treatment period or until complete wound closure
Results and safety
The study was stopped early (reason given: Project termination). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MC-8XL low level laser device and Standard wound care in people with Diabetic Foot Ulcer, run by Medical Coherence LLC at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 9 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Project termination). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety (time frame: On a weekly basis until the end of the 16 week treatment period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2020.