Effect of the Use of Low Intensity Therapeutic LASER

Federal University of Piaui

Status: Completed

Conditions: Wound; Diabetic Foot; LTBI

Treatments: Device: LG2; Procedure: Dressing; Device: LG1; Device: CC; Device: LG3

Study type: Interventional

Funder types: Other

Identifiers

NCT05530486

5.588.474

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 100 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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100 participants in 4 patient groups, including a placebo group

Comparador de placebo: CC + curativo

Placebo Comparator group

Description:

The group will receive placebo LASER application associated with Helianthus annuus oil dressing.

Treatment:

Device: CC

Procedure: Dressing

Comparador ativo: LG1 + curativo

Active Comparator group

Description:

The group will receive application of LASER Gallium Arsenide (GasAs) 660 nm 4 J/cm² associated with Helianthus annuus oil dressing.

Treatment:

Device: LG1

Procedure: Dressing

Comparador ativo: LG2 + curativo

Active Comparator group

Description:

The group will receive application of LASER Gallium Arsenide (GaAs) 660 nm 8 J/cm² associated with Helianthus annuus oil dressing.

Treatment:

Procedure: Dressing

Device: LG2

Comparador ativo: LG3 + curativo

Active Comparator group

Description:

The group will receive application of LASER Gallium Arsenide (GaAs) 660 nm 12 J/cm² associated with Helianthus annuus oil dressing.

Treatment:

Device: LG3

Procedure: Dressing