Skip to content

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
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05530486
Enrollment
100
Registered
2022-09-07
Start date
2023-06-30
Completion date
2025-05-30
Last updated
2025-06-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Wound, Diabetic Foot, LTBI

Keywords

Diabetes Mellitus, Low-Level Light Therapy, Diabetic Foot

Brief 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.

Interventions

DEVICECC

Application of placebo LASER

DEVICELG1

Application of LASER GasAs 660nm 4 J/cm².

DEVICELG2

Application of LASER GasAs 660nm 8 J/cm².

DEVICELG3

Application of LASER GasAs 660nm 12 J/cm².

PROCEDUREDressing

Application of Helianthus annuus oil dressing.

Sponsors

Federal University of Piaui
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Change in the ulcer areaBefore intervention starts, 5th and 10th week of intervention.Measure of ulcer area change.
Change in complete ulcer healingBefore intervention starts, 5th and 10th week of intervention.Change in the percentage of complete ulcer healing.

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026