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

Status Not yet recruiting

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	NCT04796649
Study type	Interventional
Source	Erika Carmel ltd
Contact	Ilan Friedman, M.D.
Phone	+972-50-7163046
Email	friedmanilan@gmail.com
Status	Not yet recruiting
Phase	N/A
Start date	May 15, 2022
Completion date	December 15, 2024

View Details

See also
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