Diabete Type 2, Diabetic Foot Ulcer, Low Level Laser Therapy, Photobiomodulation
Conditions
Keywords
diabetic foot ulcer, photobiomodulation, low level laser therapy
Brief summary
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
DEVICELow Level Laser Therapy
Painless, non-invasive treatment
Sponsors
Federal University of Piaui
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ulcer area reduction rate | Pre-intervention, five weeks and ten weeks of treatment | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| University of Texas Rankings | Pre-intervention, five weeks and ten weeks of treatment | 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). |
| Quality of life assessment | Pre-intervention, five weeks and ten weeks of treatment | 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. |
| Glycemic level assessment | Once a week for ten weeks (20 sessions) | Volunteers' blood glucose levels will be checked once a week throughout treatment. |
| Analysis of healing time and recurrence rate | Quarterly follow-up (3 months) after initial healing | 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. |
Contacts
Primary ContactVinicius Saura Vinicius Saura Cardoso
Outcome results
None listed