Effects and Feasibility of Photobiomodulation at 830nm Nanometers in the Treatment of Diabetic Ulcers
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Low Level Laser Therapy.
- Who it may be relevant to
- Registry conditions: Diabete Type 2, Diabetic Foot Ulcer, Photobiomodulation, Low Level Laser Therapy. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Effects and Feasibility of Photobiomodulation at 830 Nanometers in the Treatment of Diabetic Ulcers: a Randomized, Double-blind Clinical Trial
Overview
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.
Interventions
- Device Low Level Laser Therapy
Painless, non-invasive treatment
Primary outcome measures
- Ulcer area reduction rate [Time frame: Pre-intervention, five weeks and ten weeks of treatment]
Secondary outcome measures (4)
- University of Texas Rankings [Time frame: Pre-intervention, five weeks and ten weeks of treatment]
- Quality of life assessment [Time frame: Pre-intervention, five weeks and ten weeks of treatment]
- Glycemic level assessment [Time frame: Once a week for ten weeks (20 sessions)]
- Analysis of healing time and recurrence rate [Time frame: Quarterly follow-up (3 months) after initial healing]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Factorial
- Masking
- Triple blind
- Primary purpose
- Health services research
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07043868 · 7.488.044