Laser Therapy for At-Home Treatment of DIabetic Foot Ulcers (LLL&DIAB-03)
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
1 other identifier
interventional
60
1 country
1
Brief 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. 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started May 2022
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 11, 2021
CompletedFirst Posted
Study publicly available on registry
March 15, 2021
CompletedStudy Start
First participant enrolled
May 15, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 15, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 15, 2024
CompletedApril 28, 2022
April 1, 2022
1.6 years
March 11, 2021
April 27, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Incidence of complete (100%) wound closure
Complete re-epithelialization without drainage
up to 3 months
Secondary Outcomes (1)
Time to complete (100%) wound closure
up to 3 months
Study Arms (2)
Standard and B-Cure Pro
EXPERIMENTALSubjects 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 COMPARATORThe 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.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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
- 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
You may not qualify if:
- 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
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Erika Carmel ltdlead
Study Sites (1)
Shaare Zedek Medical Center
Jerusalem, Israel
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Nachum Greenberg, M.D
Shaare Zedek Medical Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Masking Details
- sham control
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 11, 2021
First Posted
March 15, 2021
Study Start
May 15, 2022
Primary Completion
December 15, 2023
Study Completion
December 15, 2024
Last Updated
April 28, 2022
Record last verified: 2022-04