Low-level Laser Therapy for the Treatment of Diabetic Foot Ulcer

Not Applicable

Completed

• Conditions: Diabetic Foot Ulcer
• Interventions: Procedure: Control LED shoe arm; Procedure: Laser Shoe arm

• Registration Number: NCT03788642
• Lead Sponsor: Mahidol University

Brief Summary

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).

Detailed Description

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).

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2018-12-25
• Study First Submitted QC: 2018-12-25
• Study First Posted: 2018-12-27
• Study Start: 2019-01-15
• Primary Completion: 2021-10-31
• Study Completion: 2021-10-31
• Status Verified: 2021-12
• Last Update Submitted: 2021-12-16
• Last Update Posted: 2021-12-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Patients with chronic diabetic foot ulcer
• Ankle brachial index ≥ 0.4
• Toe pressure brachial index ≥ 0.3
• Transcutaneous oxygen measurement (TCOM) ≥ 40 mmHg
• Ulcer size less than 25 cm2

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Exclusion Criteria

• Infected ulcer
• Fever
• HbA1C > 15 %

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control LED Shoe arm	Control LED shoe arm	Patients with DFU will wear LED shoe 30 minutes per day
Laser Shoe arm	Laser Shoe arm	Patients with DFU will wear Laser shoe 30 minutes per day

Primary Outcome Measures

Name	Time	Method
Ulcer Healing Rate	12 weeks	Healing rate of control and laser group will be reported at 12 weeks

Secondary Outcome Measures

Name	Time	Method
Time to ulcer healing	time from date of randomisation to date of healing within the 12 month study period	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.
Clinical Success - Complications	up to 12 months	Incidence of complications related to the LLT shoe

Trial Locations

Locations (1)

Vascular Surgery, Siriraj Hospital, Mahidol University; 🇹🇭 Bangkoknoi, Bangkok, Thailand