Laser Therapy for At-Home Treatment of DIabetic Foot Ulcers (LLL&DIAB-01)

  • End date
    Oct 1, 2023
  • participants needed
  • sponsor
    Erika Carmel ltd
Updated on 27 February 2022
type 2 diabetes mellitus
arterial perfusion
healing ulcer
foot ulcer


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.


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.

Condition Diabetic Foot Ulcer
Treatment SHAM, B-Cure Pro
Clinical Study IdentifierNCT03687320
SponsorErika Carmel ltd
Last Modified on27 February 2022


Yes No Not Sure

Inclusion Criteria

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 3 months prior to the screening visit
Ulcer grade classified as ≤3 according to Wagner grading system or IA according to University of Texas Classification of Diabetic Foot Ulcers
Area of ulcer (after debridement) is at least 4 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

Exclusion Criteria

Pre-existing conditions - evidence of gangrene on any part of affected limb, active Charcot's foot on the study limb; infection at time of screening, deep vein thrombosis (DVT), active malignancy, being on dialysis, 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 10 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
Used oral, or IV antibiotic/antimicrobial agents or medications within 7 days of baseline
Has serum albumin level of<3 mg%
Presence of ulcers due to other causes not related to diabetes
HbA1c > 12% (uncontrolled hyperglycemia)
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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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