Effect of the Use of Low Intensity Therapeutic LASER
- Conditions
- WoundDiabetic FootLTBI
- Interventions
- Device: CCDevice: LG1Device: LG3Device: LG2Procedure: Dressing
- Registration Number
- NCT05530486
- Lead Sponsor
- Federal University of Piaui
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 100
- Type 2 diabetes mellitus patients with diabetic foot ulcers;
- Patients aged 18 and over.
- Patients with autoimmune diseases
- Patients with concomitant psychiatric disorders
- Patients with contraindications to treatment methods
- Patients with infected diabetic foot ulcers.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Arm && Interventions
Group Intervention Description Comparador de placebo: CC + curativo CC The group will receive placebo LASER application associated with Helianthus annuus oil dressing. Comparador de placebo: CC + curativo Dressing The group will receive placebo LASER application associated with Helianthus annuus oil dressing. Comparador ativo: LG1 + curativo LG1 The group will receive application of LASER Gallium Arsenide (GasAs) 660 nm 4 J/cm² associated with Helianthus annuus oil dressing. Comparador ativo: LG3 + curativo LG3 The group will receive application of LASER Gallium Arsenide (GaAs) 660 nm 12 J/cm² associated with Helianthus annuus oil dressing. Comparador ativo: LG1 + curativo Dressing The group will receive application of LASER Gallium Arsenide (GasAs) 660 nm 4 J/cm² associated with Helianthus annuus oil dressing. Comparador ativo: LG3 + curativo Dressing The group will receive application of LASER Gallium Arsenide (GaAs) 660 nm 12 J/cm² associated with Helianthus annuus oil dressing. Comparador ativo: LG2 + curativo LG2 The group will receive application of LASER Gallium Arsenide (GaAs) 660 nm 8 J/cm² associated with Helianthus annuus oil dressing. Comparador ativo: LG2 + curativo Dressing The group will receive application of LASER Gallium Arsenide (GaAs) 660 nm 8 J/cm² associated with Helianthus annuus oil dressing.
- Primary Outcome Measures
Name Time Method Change in complete ulcer healing Before intervention starts, 5th and 10th week of intervention. Change in the percentage of complete ulcer healing.
Change in the ulcer area Before intervention starts, 5th and 10th week of intervention. Measure of ulcer area change.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Federal University of Piaui
🇧🇷Parnaíba, Piauí, Brazil