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

Sponsor
Federal University of Piaui
Study ID
NCT07043868
Status
Not Yet Recruiting

Notify me when recruiting opens

Save your spot on the interest list for this study. We'll keep your details with this study so our team can follow up when recruiting opens.

Not yet recruiting

Add your contact details and location so we can keep your interest tied to this study.

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Low Level Laser Therapy — DEVICE
    Painless, non-invasive treatment

Study Details

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.

Key Dates

First listed
Jun 29, 2025
Start date
Jan 10, 2026
Status verified
Jul 2025
Primary completion
Jan 10, 2027
Completion
Jan 10, 2028

Study Design

Enrollment
136 participants (estimated)
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
HEALTH_SERVICES_RESEARCH

Arms

  • Active Comparator: CG + conventional dressing
    The group will receive application of Gallium Arsenide LASER (GasAs) 904nm 10J/cm2 associated with Helianthus annuus oil dressing.
  • Experimental: GL1 4J/cm2 +conventional dressing
    The group will receive application of Gallium Arsenide LASER (GasAs) 830nm 4 J/cm² associated with Helianthus annuus oil dressing.
  • Experimental: GL2 8J/cm2 +conventional dressing
    The group will receive application of Gallium Arsenide LASER (GasAs) 830nm 8J/cm² associated with Helianthus annuus oil dressing.
  • Experimental: GL1 12J/cm2 +conventional dressing
    The group will receive application of Gallium Arsenide LASER (GasAs) 830nm 12J/cm² associated with Helianthus annuus oil dressing.

Primary Outcome Measure

Ulcer area reduction rate [ Time Frame: Pre-intervention, five weeks and ten weeks of treatment ]

Central Contacts

Related Studies