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

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.

Study Overview

• Status: Recruiting
• Conditions: Diabetic Foot Ulcer
• Intervention / Treatment: Device: Sham; Device: B-Cure Pro

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: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Itay Avni; Phone Number: +972-52-6045211; Email: itayavni@gd-energies.com

Study Locations

• Israel
  • Tel Aviv, Israel
    • Recruiting
    • Department of Orthopedic Surgery, Tel Aviv Sourasky Medical Center, Sackler Faculty of Medicine, Tel Aviv University
    • Contact: Oleg Dolkart, PhD; Phone Number: 972-52-4262544; Email: olegd@tlvmc.gov.il

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 3 months prior to the screening visit
7. Ulcer grade classified as ≤3 according to Wagner grading system or IA according to University of Texas Classification of Diabetic Foot Ulcers.
8. Area of ulcer (after debridement) is at least 4 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, 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)
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 10 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. Used oral, or IV antibiotic/antimicrobial agents or medications within 7 days of baseline
8. Has serum albumin level of<3 mg%
9. Presence of ulcers due to other causes not related to diabetes
10. HbA1c > 12% (uncontrolled hyperglycemia)
11. A documented history of alcohol or substance abuse within 6 months of screening
12. 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
13. Pregnant at the time of screening
14. Has any Photobiomodulation (low level laser) device at home

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Device: B-Cure 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.
Sham Comparator: Standard and Sham; Subjects from the Standard and sham group will receive standard care and in addition will self-treat at home daily with the sham B-Cure device.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of complete (100%) wound closure	Complete re-epithelialization without drainage	up to 3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to complete (100%) wound closure	Time to complete re-epithelialization without drainage	up to 3 months

Collaborators and Investigators

• Sponsor: Erika Carmel ltd
• Collaborators: Tel-Aviv Sourasky Medical Center
• Investigators: Principal Investigator: Elchanan Luger, MD, Department of Orthopedic Surgery, Sourasky Medical Center, Sackler Faculty of Medicine, Tel Aviv University

Study record dates

Study Major Dates

• Study Start (Actual): December 2, 2019
• Primary Completion (Anticipated): October 1, 2022
• Study Completion (Anticipated): October 1, 2023

Study Registration Dates

• First Submitted: September 26, 2018
• First Submitted That Met QC Criteria: September 26, 2018
• First Posted (Actual): September 27, 2018

Study Record Updates

• Last Update Posted (Actual): December 14, 2021
• Last Update Submitted That Met QC Criteria: December 13, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Keywords: Photobiomodulation; Low-Level Light Therapy; Low-Level Laser Therapy
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Skin Diseases; Endocrine System Diseases; Diabetic Angiopathies; Leg Ulcer; Skin Ulcer; Diabetes Complications; Diabetes Mellitus; Diabetic Neuropathies; Foot Diseases; Diabetic Foot; Foot Ulcer; Ulcer
• Other Study ID Numbers: TLV-0538-18

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No