Effect of the Use of Low Intensity Therapeutic LASER

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-30

Study Completion Date

2025-05-30

Brief Summary

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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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Detailed Description

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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.

Conditions

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Wound Diabetic Foot LTBI

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Comparador de placebo: CC + curativo

The group will receive placebo LASER application associated with Helianthus annuus oil dressing.

Group Type PLACEBO_COMPARATOR

CC

Intervention Type DEVICE

Application of placebo LASER

Dressing

Intervention Type PROCEDURE

Application of Helianthus annuus oil dressing.

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.

Group Type ACTIVE_COMPARATOR

LG1

Intervention Type DEVICE

Application of LASER GasAs 660nm 4 J/cm².

Dressing

Intervention Type PROCEDURE

Application of Helianthus annuus oil dressing.

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.

Group Type ACTIVE_COMPARATOR

LG2

Intervention Type DEVICE

Application of LASER GasAs 660nm 8 J/cm².

Dressing

Intervention Type PROCEDURE

Application of Helianthus annuus oil dressing.

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.

Group Type ACTIVE_COMPARATOR

LG3

Intervention Type DEVICE

Application of LASER GasAs 660nm 12 J/cm².

Dressing

Intervention Type PROCEDURE

Application of Helianthus annuus oil dressing.

Interventions

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CC

Application of placebo LASER

Intervention Type DEVICE

LG1

Application of LASER GasAs 660nm 4 J/cm².

Intervention Type DEVICE

LG2

Application of LASER GasAs 660nm 8 J/cm².

Intervention Type DEVICE

LG3

Application of LASER GasAs 660nm 12 J/cm².

Intervention Type DEVICE

Dressing

Application of Helianthus annuus oil dressing.

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No