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

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.

Study Overview

• Status: Completed
• Conditions: Diabetic Foot; Wound; LTBI
• Intervention / Treatment: Procedure: Dressing; Device: CC; Device: LG1; Device: LG2; Device: LG3

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.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • Piauí
    • Parnaíba, Piauí, Brazil, 64202-020
      • Federal University of Piaui

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

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

What is the study measuring?

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.

Collaborators and Investigators

• Sponsor: Federal University of Piaui
• Investigators: Principal Investigator: Vinicius Saura Cardoso, Federal University of Piaui

Study record dates

Study Major Dates

• Study Start (Actual): June 30, 2023
• Primary Completion (Actual): May 30, 2025
• Study Completion (Actual): May 30, 2025

Study Registration Dates

• First Submitted: September 1, 2022
• First Submitted That Met QC Criteria: September 2, 2022
• First Posted (Actual): September 7, 2022

Study Record Updates

• Last Update Posted (Actual): June 12, 2025
• Last Update Submitted That Met QC Criteria: June 10, 2025
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Diabetes Mellitus; Low-Level Light Therapy; Diabetic Foot
• Additional Relevant MeSH Terms: Endocrine System Diseases; Vascular Diseases; Cardiovascular Diseases; Diabetes Mellitus; Diabetic Angiopathies; Diabetes Complications; Skin Diseases; Skin Ulcer; Leg Ulcer; Diabetic Neuropathies; Foot Ulcer; Diabetic Foot
• Other Study ID Numbers: 5.588.474

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No