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

Diabetic Foot Ulcer Clinical Trial

Official title:
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

Clinical Trial 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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03687320
Study type Interventional
Source Erika Carmel ltd
Contact Itay Avni
Phone +972-52-6045211
Email itayavni@gd-energies.com
Status Recruiting
Phase N/A
Start date December 2, 2019
Completion date October 1, 2023
View Details
See also
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