NCT04796649

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Erika Carmel ltd · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-05-15
• Primary completion: 2023-12-15
• Completion: 2024-12-15
• First posted: 2021-03-15
• Last updated: 2022-04-28

Locations

1 site across 1 country: Israel