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

Study Overview
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Brief Summary
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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
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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).

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

Conditions
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Diabetic Foot Ulcer

Intervention / Treatment
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* Procedure: Control LED shoe arm
* Procedure: Laser Shoe arm


Participation Criteria
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Eligibility Criteria
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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 Exclusion Criteria: Infected ulcer Fever HbA1C > 15 %

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The randomised clinical trial with participants randomised1:1 to either Control group : Patients will wear LED shoe (Placebo) 30 minutes once daily Laser group : Patients will wear Laser shoe 30 minutes once daily
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control LED Shoe arm<br>Patients with DFU will wear LED shoe 30 minutes per day | Procedure: Control LED shoe arm<br>* Patients with DFU will wear LED shoe 30 minutes once daily<br>|
| Active Comparator: Laser Shoe arm<br>Patients with DFU will wear Laser shoe 30 minutes per day | Procedure: Laser Shoe arm<br>* Patients with DFU will wear Laser shoe 30 minutes once daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ulcer Healing Rate | Healing rate of control and laser group will be reported at 12 weeks | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 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 | up to 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetic Foot Ulcer, Low Level Laser Therapy