Effect of the Use of Low Intensity Therapeutic LASER

Diabetic Foot Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05530486
• Other study ID #: 5.588.474
• Status: Recruiting
• Phase: N/A
• Start date: June 30, 2023
• Est. completion date: November 30, 2026

Study information

• Verified date: March 2024
• Source: Federal University of Piaui
• Contact: Vinicius Saura Cardoso
• Phone: 55 86 99984-2919
• Email: vscfisio[@]ufpi.edu.br
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: November 30, 2026
• Est. primary completion date: May 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetic Foot
• LTBI
• Wound

Intervention

Device:
• CC
Application of placebo LASER
• LG1
Application of LASER GasAs 660nm 4 J/cm².
• LG2
Application of LASER GasAs 660nm 8 J/cm².
• LG3
Application of LASER GasAs 660nm 12 J/cm².

Procedure:
• Dressing
Application of Helianthus annuus oil dressing.

Locations

Country	Name	City	State
Brazil	Federal University of Piaui	Parnaíba	Piauí

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of Piaui

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in the ulcer area	Measure of ulcer area change.	Before intervention starts, 5th and 10th week of intervention.
Primary	Change in complete ulcer healing	Change in the percentage of complete ulcer healing.	Before intervention starts, 5th and 10th week of intervention.