Laser Therapy for At-Home Treatment of DIabetic Foot Ulcers

NCT ID: NCT03687320

Last Updated: 2021-12-14

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-12-02
• Study Completion Date: 2023-10-01

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.

Conditions

Diabetic Foot Ulcer

Keywords

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: EXPERIMENTAL

B-Cure Pro

Intervention Type: 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 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.

Group Type: SHAM_COMPARATOR

Sham

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tel-Aviv Sourasky Medical Center

OTHER_GOV

Sponsor Role: collaborator

Erika Carmel ltd

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Elchanan Luger, MD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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

Tel Aviv, , Israel

Site Status: RECRUITING

Countries

Israel

Central Contacts

Itay Avni

Role: CONTACT

Phone: +972-52-6045211

Email: itayavni@gd-energies.com

Facility Contacts

Oleg Dolkart, PhD

Role: primary

Other Identifiers

TLV-0538-18

Identifier Type: -

Identifier Source: org_study_id