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Laser Therapy for At-Home Treatment of DIabetic Foot Ulcers (LLL&DIAB-03)

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ClinicalTrials.gov Identifier: NCT04796649
Recruitment Status : Not yet recruiting
First Posted : March 15, 2021
Last Update Posted : March 15, 2021
Sponsor:
Information provided by (Responsible Party):
Erika Carmel ltd

Tracking Information
First Submitted Date  ICMJE March 11, 2021
First Posted Date  ICMJE March 15, 2021
Last Update Posted Date March 15, 2021
Estimated Study Start Date  ICMJE April 15, 2021
Estimated Primary Completion Date April 15, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 11, 2021)
Incidence of complete (100%) wound closure [ Time Frame: up to 3 months ]
Complete re-epithelialization without drainage
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: March 11, 2021)
Time to complete (100%) wound closure [ Time Frame: up to 3 months ]
Time to complete re-epithelialization without drainage
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Laser Therapy for At-Home Treatment of DIabetic Foot Ulcers (LLL&DIAB-03)
Official Title  ICMJE 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
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

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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Single center, Prospective, Double Blind, Randomized, Sham-Controlled, Parallel Group, Superiority comparison
Masking: Double (Participant, Investigator)
Masking Description:
sham control
Primary Purpose: Treatment
Condition  ICMJE Diabetic Foot Ulcer
Intervention  ICMJE
  • Device: B-Cure laser pro
    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.
  • Device: Sham
    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 Arms  ICMJE
  • Experimental: Standard and B-Cure Pro
    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.
    Intervention: Device: B-Cure laser pro
  • Active Comparator: Standard treatment + Sham laser
    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.
    Intervention: Device: Sham
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: March 11, 2021)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 15, 2022
Estimated Primary Completion Date April 15, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Provision of signed and dated informed consent form
  2. Stated willingness to comply with all study procedures and availability for the duration of the study
  3. Male or Female
  4. Age:18-90 years old at the time of Informed Consent (Adult, Senior)
  5. Type 1 or type 2 Diabetes Mellitus
  6. 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
  7. Ulcer grade classified as ≤ IIIA according to University of Texas Classification of Diabetic Foot Ulcers.
  8. Area of ulcer (after debridement) is at least 2 cm2
  9. 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
  10. Patient and/or caregiver must be able and willing to learn and perform the duties of dressing changes
  11. 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:

  1. 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)
  2. Known allergies to dressing materials, including occlusive dressings and the adhesives on such dressings
  3. Scheduled to undergo vascular surgery, angioplasty or thrombolysis at the time of enrollment or history of peripheral vascular repair within 4 weeks of screening
  4. History of malignancy on study limb or currently receiving or has received radiation or chemotherapy within 3 months of randomization
  5. Taking immunosuppressive medication
  6. Received growth factor therapy (e.g., autologous platelet-rich plasma gel, becaplermin, bilayered cell therapy, dermal substitute, extracellular matrix) within two weeks of screening
  7. Has serum albumin level of<3 mg%
  8. A documented history of alcohol or substance abuse within 6 months of screening
  9. 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
  10. Pregnant at the time of screening
  11. Has any photobiomodulation (low level laser) device at home
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Ilan Friedman, M.D. +972-50-7163046 friedmanilan@gmail.com
Contact: Assaf Hamawi, M.D assafyehu@gmail.com
Listed Location Countries  ICMJE Israel
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04796649
Other Study ID Numbers  ICMJE 0550-20-SZMC
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Erika Carmel ltd
Study Sponsor  ICMJE Erika Carmel ltd
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Nachum Greenberg, M.D Shaare Zedek Medical Center
PRS Account Erika Carmel ltd
Verification Date March 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP