An interventional study of Low Level Laser Therapy in Diabete Type 2, Diabetic Foot Ulcer and Photobiomodulation, sponsored by Federal University of Piaui. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-07-10.
Sponsored by Federal University of Piaui · Not applicable, Interventional, and Health services research
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.
9,359 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,318 are open to participants now.
This study's planned enrollment of 136 is above the median of 80 across 7,525 interventional studies indexed under Diabetes Mellitus, Type 2.
Browse Diabetes Mellitus, Type 2 studies →Federal University of Piaui is the lead sponsor of 11 studies on the registry; 5 are open to participants now.
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Exclusion Criteria:
The group will receive application of Gallium Arsenide LASER (GasAs) 904nm 10J/cm2 associated with Helianthus annuus oil dressing.
Device: Low Level Laser Therapy
The group will receive application of Gallium Arsenide LASER (GasAs) 830nm 4 J/cm² associated with Helianthus annuus oil dressing.
Device: Low Level Laser Therapy
The group will receive application of Gallium Arsenide LASER (GasAs) 830nm 8J/cm² associated with Helianthus annuus oil dressing.
Device: Low Level Laser Therapy
The group will receive application of Gallium Arsenide LASER (GasAs) 830nm 12J/cm² associated with Helianthus annuus oil dressing.
Device: Low Level Laser Therapy
Painless, non-invasive treatment
Also known as: Photobiomodulation
Ulcer area reduction rate
The ulcers will be measured with a paper ruler and photographed for later analysis of the images using the ImageJ program. The paper ruler will be positioned to measure the length and width of the ulcers.
Time frame: Pre-intervention, five weeks and ten weeks of treatment
University of Texas Rankings
For analysis of ulcer depth, volunteers will be grouped into A1 and C1 (superficial ulcers), A2 and C2 (ulcers involving tendon or joint capsule) and A3 (ulcers involving bone).
Time frame: Pre-intervention, five weeks and ten weeks of treatment
Quality of life assessment
The EQ-5D tool will be used, consisting of five questions that assess the following aspects: mobility, personal care, usual activities, pain or discomfort, and anxiety/depression.
Time frame: Pre-intervention, five weeks and ten weeks of treatment
Glycemic level assessment
Volunteers' blood glucose levels will be checked once a week throughout treatment.
Time frame: Once a week for ten weeks (20 sessions)
Analysis of healing time and recurrence rate
Healing time:Difference, in days, between the date of the first clinical record of the lesion and the date on which the wound is considered fully healed, characterized by complete epithelialization, absence of secretion and necrotic tissue.Recurrence: assessed based on the difference, in days, between the date of complete healing and the record of recurrence of the lesion in the same region, major amputation, death or the end of the study period.
Time frame: Quarterly follow-up (3 months) after initial healing
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.
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Federal University of Piaui