Effects and Feasibility of Photobiomodulation at 830nm Nanometers in the Treatment of Diabetic Ulcers

Federal University of Piaui

Status: Not yet enrolling

Conditions: Low Level Laser Therapy; Photobiomodulation; Diabetic Foot Ulcer; Diabete Type 2

Treatments: Device: Low Level Laser Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT07043868

7.488.044

Details and patient eligibility

About

Diabetic foot ulcers (DFU) are among the late complications of DFU, defined as skin lesions that involve the dermis to deeper structures, such as muscles and bones. Although preclinical studies have demonstrated the effects of GaAs 830 nm in diabetic wounds, no clinical studies have been performed, revealing the need for more in-depth analyses to identify the effects and ideal parameterization of PBM with GaAs 830 nm wavelength in the treatment of diabetic ulcers, improving quality of life, as well as to understand the therapeutic feasibility, time required for healing and recurrence rates of these lesions. Experimental, randomized, controlled, double-blind study, with blinding applied to the evaluator and participants. A total of 136 volunteers will be recruited for the research, carried out at the Integrated Center of Medical Specialties (CIEM) - Polyclinic. LLLT GaAs 830nm will be used with three dosages of low, medium and high intensity (4 J/cm², 8 J/cm², 12 J/cm²). The study will have three intervention groups using LLLT with GaAs 830nm and a control group, in which LLLLT will be performed with a GaAs 904nm wavelength and a dose of 10 J/cm², according to Saura et al (2024). This study was approved by the local Research Ethics Committee (Opinion 7,488,044), conducted in accordance with the Declaration of Helsinki and in accordance with the CONSORT (Consolidated Standards of Reporting Trials) guidelines.

Enrollment: 136 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Volunteers of both sexes
• Age over 18 years
• Medical diagnosis of diabetes mellitus (DM)
• Presence of diabetic ulcer

Exclusion criteria

• Autoimmune diseases
• Infected diabetic ulcers
• Osteomyelitis
• Ischemia
• Concomitant psychiatric disorders
• Contraindications to treatment methods

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Triple Blind

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136 participants in 4 patient groups

CG + conventional dressing

Active Comparator group

Description:

The group will receive application of Gallium Arsenide LASER (GasAs) 904nm 10J/cm2 associated with Helianthus annuus oil dressing.

Treatment:

Device: Low Level Laser Therapy

GL1 4J/cm2 +conventional dressing

Experimental group

Description:

The group will receive application of Gallium Arsenide LASER (GasAs) 830nm 4 J/cm² associated with Helianthus annuus oil dressing.

Treatment:

Device: Low Level Laser Therapy

GL2 8J/cm2 +conventional dressing

Experimental group

Description:

The group will receive application of Gallium Arsenide LASER (GasAs) 830nm 8J/cm² associated with Helianthus annuus oil dressing.

Treatment:

Device: Low Level Laser Therapy

GL1 12J/cm2 +conventional dressing

Experimental group

Description:

The group will receive application of Gallium Arsenide LASER (GasAs) 830nm 12J/cm² associated with Helianthus annuus oil dressing.

Treatment:

Device: Low Level Laser Therapy