Diabetic Foot UlcerNCT04796649
Laser Therapy for At-Home Treatment of DIabetic Foot Ulcers (LLL&DIAB-03)
A study testing B-Cure laser pro in people with Diabetic Foot Ulcer, run by Erika Carmel ltd at 1 site in Israel.
Trial summary
The global prevalence of diabetes is on the rise and with it increase in prevalence of diabetic foot ulcers (DFU). These recalcitrant wounds are difficult to manage and pose a heavy economic burden. Photobiomodulation (low-level laser) is used for acceleration of wound healing. 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?
- B-Cure laser pro
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteIsrael
- Study dates
- 15 May 2022to 15 Dec 2024
- 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
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Male or Female
- Age:18-90 years old at the time of Informed Consent (Adult, Senior)
- Type 1 or type 2 Diabetes Mellitus
- Presence of a diabetic foot ulcer located in the ankle area or below that has persisted a minimum of 4 weeks prior to the screening visit
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- Ulcer grade classified as ≤ IIIA according to University of Texas Classification of Diabetic Foot Ulcers.
- Area of ulcer (after debridement) is at least 2 cm2
- Arterial perfusion: Patients who demonstrate adequate arterial perfusion defined as either: Ankle/brachial index (ABI) above 0.7 or that have documented confirmation of adequate arterial perfusion
- Patient and/or caregiver must be able and willing to learn and perform the duties of dressing changes
- For females of reproductive potential: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation
Who cannot join
- Pre-existing conditions - evidence of gangrene on any part of affected limb infection at time of screening, deep vein thrombosis (DVT), active malignancy, anemia (Hb<9 gr/dL)
- Known allergies to dressing materials, including occlusive dressings and the adhesives on such dressings
- Scheduled to undergo vascular surgery, angioplasty or thrombolysis at the time of enrollment or history of peripheral vascular repair within 4 weeks of screening
- History of malignancy on study limb or currently receiving or has received radiation or chemotherapy within 3 months of randomization
- Taking immunosuppressive medication
- Received growth factor therapy (e.g., autologous platelet-rich plasma gel, becaplermin, bilayered cell therapy, dermal substitute, extracellular matrix) within two weeks of screening
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- Has serum albumin level of<3 mg%
- A documented history of alcohol or substance abuse within 6 months of screening
- Currently enrolled or who have participated, within 30 days of screening, in another investigational device, drug or biological trial that may interfere with study results
- Pregnant at the time of screening
- Has any photobiomodulation (low level laser) device at home
Trial locations and contacts
1 site in 1 country.
Assaf Hamawi, M.D contact
About this study
Official title: Effectiveness and Safety of a Home-Use Low Level Laser Therapy Device as an Adjunct to Standard Treatment Compared to Standard Treatment Alone, for Diabetic Foot Ulcers: A Double Blind, Randomized, Sham-Controlled Clinical Study
The global prevalence of diabetes is on the rise and with it increase in prevalence of diabetic foot ulcers (DFU). These recalcitrant wounds are difficult to manage and pose a heavy economic burden. Photobiomodulation (low-level laser) is used for acceleration of wound healing.
The current study is designed to evaluate the effectiveness of B-cure laser, a home-use low-level laser device, for acceleration of diabetic foot ulcer healing over standard treatment
Read the detailed description
Patients with diabetic foot ulcers will receive standard treatment and in addition will be randomly allocated to receive either active or sham laser device to self-treat at home. The patient's wound will be evaluated every 2 weeks. Adverse events will be documented.
The study hypothesis is that B-Cure laser treatments as an adjunct therapy to standard treatment, applied, at home, by the patient or personal care-giver, can accelerate diabetic foot ulcers healing compared to standard treatment alone.
- Conditions
- Diabetic Foot Ulcer
- Being tested
- B-Cure laser pro, Sham
- Keywords
- Photobiomodulation, Low-Level Laser, Wound Healing
- Medical subject headings
- Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
B-Cure laser proDevice
The B-Cure laser Pro is a portal, non-invasive, low level laser therapy device, that emits light in the near infrared (808nm) over an area of 1X4.5 cm2 with power output of 250mW, and energy dose of 5J/min.
ShamDevice
The sham device is externally identical to the B-Cure Pro and emit the same guiding light, but does not emit the therapeutic near infrared rays.
| Study group | Role | What they receive |
|---|---|---|
| Standard and B-Cure Pro | Experimental | Subjects from the Standard and B-Cure Pro group will receive standard care and in addition will self-treat at home daily with the B-Cure device. Receives: Device: B-Cure laser pro |
| Standard treatment + Sham laser | Active comparator | The sham device is externally identical to the B-Cure Pro and emit the same guiding light, but does not emit the therapeutic near infrared rays. Receives: Device: Sham |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of complete (100%) wound closure
Complete re-epithelialization without drainage
Measured: up to 3 months
Secondary outcomes (1)
Time to complete (100%) wound closure
Time to complete re-epithelialization without drainage
Measured: up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2021
- Study start15 May 2022 (estimated)
- Primary completion15 Dec 2023 (estimated)
- Study completion15 Dec 2024 (estimated)
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Single center, Prospective, Double Blind, Randomized, Sham-Controlled, Parallel Group, Superiority comparison
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Erika Carmel ltd
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nachum Greenberg, M.D, Principal investigator, Shaare Zedek Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04796649
- Sponsor's protocol ID
- 0550-20-SZMC
- Status last verified
- Apr 2022
- First submitted
- 11 Mar 2021
- Last updated
- 28 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness and Safety of a Home-Use Low Level Laser Therapy Device as an Adjunct to Standard Treatment Compared to Standard Treatment Alone, for Diabetic Foot Ulcers: A Double Blind, Randomized, Sham-Controlled Clinical Study
- ClinicalTrials.gov ID
- NCT04796649
- Acronym / sponsor ID
- 0550-20-SZMC
- Conditions
- Diabetic Foot Ulcer
- Keywords
- Photobiomodulation, Low-Level Laser, Wound Healing
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Erika Carmel ltdUniversity, hospital or other
- Study start
- 15 May 2022 (estimated)
- Primary completion
- 15 Dec 2023 (estimated)
- Study completion
- 15 Dec 2024 (estimated)
- First posted
- 15 Mar 2021 (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.
The global prevalence of diabetes is on the rise and with it increase in prevalence of diabetic foot ulcers (DFU). These recalcitrant wounds are difficult to manage and pose a heavy economic burden. Photobiomodulation (low-level laser) is used for acceleration of wound healing.
The current study is designed to evaluate the effectiveness of B-cure laser, a home-use low-level laser device, for acceleration of diabetic foot ulcer healing over standard treatment
Detailed description
Patients with diabetic foot ulcers will receive standard treatment and in addition will be randomly allocated to receive either active or sham laser device to self-treat at home. The patient's wound will be evaluated every 2 weeks. Adverse events will be documented.
The study hypothesis is that B-Cure laser treatments as an adjunct therapy to standard treatment, applied, at home, by the patient or personal care-giver, can accelerate diabetic foot ulcers healing compared to standard treatment alone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Single center, Prospective, Double Blind, Randomized, Sham-Controlled, Parallel Group, Superiority comparison
| Arm | Type | Receives |
|---|---|---|
| Standard and B-Cure Pro | Experimental | Device: B-Cure laser proSubjects from the Standard and B-Cure Pro group will receive standard care and in addition will self-treat at home daily with the B-Cure device. |
| Standard treatment + Sham laser | Active comparator | Device: ShamThe sham device is externally identical to the B-Cure Pro and emit the same guiding light, but does not emit the therapeutic near infrared rays. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Male or Female
- Age:18-90 years old at the time of Informed Consent (Adult, Senior)
- Type 1 or type 2 Diabetes Mellitus
Key exclusion criteria (11 listed)
- Pre-existing conditions - evidence of gangrene on any part of affected limb infection at time of screening, deep vein thrombosis (DVT), active malignancy, anemia (Hb<9 gr/dL)
- Known allergies to dressing materials, including occlusive dressings and the adhesives on such dressings
- Scheduled to undergo vascular surgery, angioplasty or thrombolysis at the time of enrollment or history of peripheral vascular repair within 4 weeks of screening
- History of malignancy on study limb or currently receiving or has received radiation or chemotherapy within 3 months of randomization
- Taking immunosuppressive medication
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 |
|---|---|---|
| B-Cure laser proThe B-Cure laser Pro is a portal, non-invasive, low level laser therapy device, that emits light in the near infrared (808nm) over an area of 1X4.5 cm2 with power output of 250mW, and energy dose of 5J/min. | Device | Standard and B-Cure Pro |
| ShamThe sham device is externally identical to the B-Cure Pro and emit the same guiding light, but does not emit the therapeutic near infrared rays. | Device | Standard treatment + Sham laser |
Primary outcome
Incidence of complete (100%) wound closure
Time frame: up to 3 months
Complete re-epithelialization without drainage
1 secondary outcome
Time to complete (100%) wound closure
Time frame: up to 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2022.
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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.
Assaf Hamawi, M.D contact
Nachum Greenberg, M.D principal investigator
Shaare Zedek Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing B-Cure laser pro in people with Diabetic Foot Ulcer, run by Erika Carmel ltd 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 11 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 28 Apr 2022. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ilan Friedman, M.D. (+972-50-7163046, friedmanilan@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of complete (100%) wound closure (time frame: up to 3 months). 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 28 Apr 2022.