The study evaluates the efficacy of Low-level laser therapy on ulcer healing in patients with diabetic foot ulcer. Half the patients are randomized to receive Low-level laser therapy and a half to recieve the placebo (LED).
Low-level laser therapy(LLLT) has been reported to aid ulcer healing in patients with diabetic foot ulcer. However, patients need to come to hospital to receive LLLT performed by medical professional. The LLLT shoe has been developed for home using. Patients can wear LLLT shoe 30 min once daily instead of going hospital for LLT therapy. The aim of this study is to see whether LLLT shoe helps with healing compare with placebo (LED shoe).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
20
Patients with DFU will wear LED shoe 30 minutes once daily
Patients with DFU will wear Laser shoe 30 minutes once daily
Vascular Surgery, Siriraj Hospital, Mahidol University
Bangkoknoi, Bangkok, Thailand
Ulcer Healing Rate
Healing rate of control and laser group will be reported at 12 weeks
Time frame: 12 weeks
Time to ulcer healing
For the purposes of this study, ulcer healing is defined as complete re-epithelialization of all ulceration on the randomized leg in the absence of a scab (eschar) with no dressing required.
Time frame: time from date of randomisation to date of healing within the 12 month study period
Clinical Success - Complications
Incidence of complications related to the LLT shoe
Time frame: up to 12 months
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