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OpenTrials
Completed

NCT Number: NCT05530486

Effect of the Use of Low Intensity Therapeutic LASER

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.

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Key information

Conditions

Wound Cardiovascular Diseases Diabetes Complications Diabetes Mellitus Diabetic Angiopathies Diabetic Foot Diabetic Neuropathies Endocrine System Diseases Foot Ulcer Glucose Metabolism Disorders LTBI Leg Ulcer Metabolic Diseases Nutritional and Metabolic Diseases Skin Diseases Skin Ulcer Skin and Connective Tissue Diseases Vascular Diseases Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Federal University of Piaui

Parnaíba, Piauí, 64202-020, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

CC

Device

Application of placebo LASER

LG1

Device

Application of LASER GasAs 660nm 4 J/cm².

LG2

Device

Application of LASER GasAs 660nm 8 J/cm².

LG3

Device

Application of LASER GasAs 660nm 12 J/cm².

Dressing

Procedure

Application of Helianthus annuus oil dressing.

Primary outcomes

  1. Change in the ulcer area

    Time frame: Before intervention starts, 5th and 10th week of intervention.

    Measure of ulcer area change.

  2. Change in complete ulcer healing

    Time frame: Before intervention starts, 5th and 10th week of intervention.

    Change in the percentage of complete ulcer healing.

Sponsors and collaborators

Lead sponsor

Federal University of Piaui

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Sep 7, 2022
Registry last updated
Jun 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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