Effect of the Use of Low Intensity Therapeutic LASER

Study Overview
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Brief Summary
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Diabetes mellitus consists of a heterogeneous group of metabolic disorders that have hyperglycemia in common, resulting from defects in insulin action, insulin secretion, or both. Diabetes mellitus has gained increasing importance and is considered one of the main themes of global health problems due to the damage caused to quality of life, public health and the epidemiological picture presented. Among the complications are diabetic foot ulcers, with higher prevalence in the lower limbs, they are classified as loss of skin continuity, which can reach from the epidermis to deep structures such as muscles, bones and tendons.

Detailed Description
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100 volunteers will be recruited and the research will be carried out through the Integrated Center of Medical Specialties (CIEM) - Polyclinic, through referral from the specialist in vascular surgery after a thorough examination of the feet. Volunteers of both sexes, aged over 18 years, DM and diabetic ulcers will be admitted. Volunteers who present any autoimmune disease, concomitant psychiatric disorders or contraindications to the treatment methods adopted by the research will be excluded. Inclusion in the study will take place after signing the informed consent forms, after approval by the Ethics Committee.

Official Title
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Effect of the Use of Therapeutic Low-intensity 660 nm LASER in the Treatment of Diabetic Ulcers: a Double-blind Randomized Clinical Trial

Conditions
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Wound, Diabetic Foot, LTBI

Intervention / Treatment
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* Device: CC
* Device: LG1
* Device: LG2
* Device: LG3
* 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: Patients with autoimmune diseases Patients with concomitant psychiatric disorders Patients with contraindications to treatment methods Patients with infected diabetic foot ulcers.

Ages Eligible for Study
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Minimum Age: 18 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: Health Services Research
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Comparador de placebo: CC + curativo<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: Comparador ativo: LG1 + curativo<br>The group will receive application of LASER Gallium Arsenide (GasAs) 660 nm 4 J/cm² associated with Helianthus annuus oil dressing. | Device: LG1<br>* Application of LASER GasAs 660nm 4 J/cm².<br>Procedure: Dressing<br>* Application of Helianthus annuus oil dressing.<br>|
| Active Comparator: Comparador ativo: LG2 + curativo<br>The group will receive application of LASER Gallium Arsenide (GaAs) 660 nm 8 J/cm² associated with Helianthus annuus oil dressing. | Device: LG2<br>* Application of LASER GasAs 660nm 8 J/cm².<br>Procedure: Dressing<br>* Application of Helianthus annuus oil dressing.<br>|
| Active Comparator: Comparador ativo: LG3 + curativo<br>The group will receive application of LASER Gallium Arsenide (GaAs) 660 nm 12 J/cm² associated with Helianthus annuus oil dressing. | Device: LG3<br>* Application of LASER GasAs 660nm 12 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetes Mellitus, Low-Level Light Therapy, Diabetic Foot