NCT05530486

Effect of the Use of Low Intensity Therapeutic LASER

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Federal University of Piaui · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Wound
• Diabetic Foot
• LTBI

Interventions

Type	Name	Description
DEVICE	CC	Application of placebo LASER
DEVICE	LG1	Application of LASER GasAs 660nm 4 J/cm².
DEVICE	LG2	Application of LASER GasAs 660nm 8 J/cm².
DEVICE	LG3	Application of LASER GasAs 660nm 12 J/cm².
PROCEDURE	Dressing	Application of Helianthus annuus oil dressing.

Timeline

• Start date: 2023-06-30
• Primary completion: 2025-05-30
• Completion: 2025-05-30
• First posted: 2022-09-07
• Last updated: 2025-06-12

Locations

1 site across 1 country: Brazil