Effects of Transcutaneous Photobiomodulation on Diabetic Foot Ulcers.

Foot ulcers in people with diabetes mellitus represent one of the most serious chroniccomplications of the disease, being associated with persistent inflammation, highoxidative stress, microvascular dysfunction and systemic hemorheological changes thatcompromise the progression of the healing process. Given the pathophysiologicalcomplexity of these injuries, therapeutic strategies capable of acting simultaneously onthe local wound microenvironment and the systemic biological environment become relevantfor optimizing tissue repair. This study aims to evaluate the effects of the associationbetween transcutaneous vascular photobiomodulation (FBMVT) and topical photobiomodulation(FBMT) in people with diabetes and foot ulcers. This is a randomized, controlled andprospective phase II clinical trial, with a sample of 20 participants allocated toexperimental groups that will receive a standard dressing with neutral healing matrix(TLC) or a protocol combining FBMVT and FBMT. FBMVT will be performed with a 660 nmlaser, 100 mW power, continuous mode and 180 J per application, monthly for 12 weeks,totaling four sessions. FBMT will be performed with a 660 nm laser, 100 mW power, 2 Jenergy per point, twice a week during dressing changes, totaling approximately 24sessions throughout follow‐up. The primary outcome will be the reduction in the area ofthe lesion (cm²), measured using a standardized planimetric method. As secondaryoutcomes, the Pressure Ulcer Scale for Healing (PUSH) score will be evaluated, thestandardized infrared thermographic assessment of the monthly perilesional region of allparticipants and the qualitative analysis of peripheral blood by dark field microscopy(MCE) pre and post FBMVT of the intervention group. The data will be analyzed usingrepeated measures ANOVA, after evaluating the normality of the data, adopting asignificance level of 5%. It is expected to observe a reduction in the lesion area,improvement in clinical healing scores, favorable changes in the hemocirculatory dynamicsobserved in ECM and modulation of thermal patterns related to tissue perfusion,indicating that systemic and local biophotonic modulation can contribute to theoptimization of the healing process in foot ulcers in people with diabetes.