Laser Therapy for At-Home Treatment of DIabetic Foot Ulcers

NCT03687320 | Unknown DMC

• 1 other identifier: TLV-0538-18
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 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.

Conditions

Diabetic Foot Ulcer

Keywords

Photobiomodulation; Low-Level Light Therapy; Low-Level Laser Therapy

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

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.

Device: B-Cure Pro

Standard and Sham

SHAM COMPARATOR

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

Interventions

B-Cure Pro DEVICE

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.

Standard and B-Cure Pro

Sham DEVICE

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.

Standard and Sham

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Erika Carmel ltd: lead
• Tel-Aviv Sourasky Medical Center: collaborator

Study Sites (1)

Department of Orthopedic Surgery, Tel Aviv Sourasky Medical Center, Sackler Faculty of Medicine, Tel Aviv University

Tel Aviv, Israel

RECRUITING

MeSH Terms

Conditions

Diabetic Foot

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies

Study Officials

• Elchanan Luger, MD

  Department of Orthopedic Surgery, Sourasky Medical Center, Sackler Faculty of Medicine, Tel Aviv University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Itay Avni

CONTACT

+972-52-6045211; itayavni@gd-energies.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Sham control
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single center, Prospective, Double Blind, Randomized, Sham-Controlled, Parallel Group, Superiority comparison

Study Record Dates

• First Submitted: September 26, 2018
• First Posted: September 27, 2018
• Study Start: December 2, 2019
• Primary Completion: October 1, 2022
• Study Completion: October 1, 2023
• Last Updated: December 14, 2021

Record last verified: 2021-11

Locations

IL (1)