Use of Low-level Laser Therapy in the Treatment of Diabetic Foot Ulcers

Study Overview
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Brief Summary
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Diabetes mellitus (DM) is currently an important cause of morbidity and mortality. Global estimates indicate that 382 million people live with diabetes (8.3%), and that number could reach 592 million in 2035. The diabetic foot ulcers (DFU) present as sore wounds with disintegration of the skin. The DFU affect 15% of diabetic patients. Several studies have been conducted aiming to find therapeutic strategies for the healing of DFU, among the reported therapeutic methods the Low-level Laser Therapy (LLLT) has been highlighted. The aim of this study is to investigate the effects of different doses of LLLT in the treatment of DFU. Methods: This study is characterized as a double-blind randomized clinical trial (RCT), consisting of four groups, the control group will have only dressing and placebo LLLT application and the other three groups will have dressing and real LLLT GaAs 904 nm application. Expected outcomes: to elucidate the effects of different doses of LLLT GaAs 904 nm on the treatment of DFU, beyond to identify the most effective dose.

Detailed Description
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All groups will perform the same procedures twice weekly. Volunteers will be comfortable with the affected foot exposed. The diabetic foot ulcers (DFU) will be cleaned using saline solution and gauze, then the ulcer temperature will be checked using the digital infrared thermometer. Diabetic wounds will be measured and photographed at baseline and every 10 visits until the study is completed, the images will be analyzed using the ImageJ program for follow-up throughout the intervention. The DFU will be ranked according to the Wagner Scale. Afterwards the volunteers will receive LLLT application and conventional treatment in the form of Helianthus Annuus oil dressing. Both therapist and participant will be instructed on precautions to be observed when using LLLT. Goggles will be provided prior to administration. The lower cylinder of the LASER probe will be placed perpendicular to the DFU, the floor and edges of the ulcer will be irradiated using punctual and scanning techniques, respectively. Once a week blood glucose levels will be obtained for patient screening. All data will be recorded until the end of the visits in a control form prepared.

Official Title
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Effect of Low-level Laser Therapy in the Treatment of Diabetic Foot Ulcers: a Double-blind Randomized Controlled Trial

Conditions
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Diabetic Foot Ulcer, Diabetic Foot

Intervention / Treatment
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* Device: LG1
* Device: LG2
* Device: LG3
* Device: CC
* Procedure: Dressing


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Type 2 diabetes mellitus patients with diabetic foot ulcers; Patients aged 18 and over. Exclusion Criteria: Type 2 diabetes mellitus patients with ulcers in parts of the body other than the feet; Patients with infected diabetic foot ulcers.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 79 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
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: CC + dressing<br>The group will receive placebo LASER application associated with Helianthus annuus oil dressing. | Device: CC<br>* Application of placebo LASER.<br>Procedure: Dressing<br>* Application of Helianthus annuus oil dressing.<br>|
| Active Comparator: LG1 + dressing<br>The group will receive application of LASER Gallium Arsenide (GaAs) 904 nm 10 J/cm² associated with Helianthus annuus oil dressing. | Device: LG1<br>* Application of LASER AsGa 904nm 10 J/cm².<br>Procedure: Dressing<br>* Application of Helianthus annuus oil dressing.<br>|
| Active Comparator: LG2 + dressing<br>The group will receive application of LASER Gallium Arsenide (GaAs) 904 nm 8 J/cm² associated with Helianthus annuus oil dressing. | Device: LG2<br>* Application of LASER AsGa 904nm 8 J/cm².<br>Procedure: Dressing<br>* Application of Helianthus annuus oil dressing.<br>|
| Active Comparator: LG3 + dressing<br>The group will receive application of LASER Gallium Arsenide (GaAs) 904 nm 4 J/cm² associated with Helianthus annuus oil dressing. | Device: LG3<br>* Application of LASER AsGa 904nm 4 J/cm².<br>Procedure: Dressing<br>* Application of Helianthus annuus oil dressing.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the ulcer area | Measure of ulcer area change. | Before intervention starts, 5th and 10th week of intervention. | 
| Change in complete ulcer healing | Change in the percentage of complete ulcer healing. | Before intervention starts, 5th and 10th week of intervention. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wagner Classification | Ulcer categorization according to Wagner Classification. | Before intervention starts, 5th and 10th week of intervention and after 1 month and after 1 month. | 
| Blood glucose | Glycemic levels. | Before intervention starts, 5th and 10th week of intervention and after 1 month and after 1 month. | 
| Temperature | Ulcer temperature. | Before intervention starts, 5th and 10th week of intervention. | 
| Short Form-36 Health Survey questionnaire | The Short Form-36 Health Survey questionnaire (SF 36) assesses quality of life and consists of 36 questions, covering 8 domains. This questionnaire has a final score from 0 to 100, in which zero corresponds to the worst general health status and 100 to the best health status. | Before intervention starts, 5th and 10th week of intervention and after 1 month and after 1 month. |