Ação da terapia fotodinâmica antimicrobiana na qualidade da ferida e reparo tecidual em úlceras no pé da pessoa com diabetes: estudo clínico controlado randomizado duplo cego

Abstract

Diabetic Foot Ulcers affect approximately 10.5% of the global population, significantly impairing patients' quality of life and placing a heavy burden on public healthcare systems. Evidence suggests that antimicrobial photodynamic therapy (aPDT) may accelerate the healing of these wounds. However, the lack of robust evidence limits its widespread adoption in clinical practice. Therefore, controlled and randomized clinical trials are necessary to strengthen the level of evidence on this subject and contribute to improving the quality of life for patients affected by foot ulcers. The objective of this controlled, randomized, and double-blind clinical trial was to analyze the effect of antimicrobial photodynamic therapy (aPDT) on wound quality and tissue repair, using the Bates-Jensen Wound Assessment Tool (BWAT) in individuals with diabetic foot ulcers. A total of 94 patients were included, randomly assigned into two groups (1:1): aPDT group (n = 47): received standard wound care at the Polyclinic combined with aPDT. Control group (n = 47): received the same standard care, combined with a simulated aPDT (device turned off). Treatment sessions were held three times per week, totaling ten consecutive sessions. The device used was a cluster with four red laser emitters (660 nm), each delivering 100 mW of power and 6 J per point, totaling 24 J per session. The photosensitizer used was 1% methylene blue. The primary outcome was wound quality, assessed using the Bates-Jensen scale (BJ) on sessions 1, 3, 5, and 10, by a researcher blinded to the intervention. The BJ scale evaluates multiple parameters, including wound size, depth, edges, type and amount of necrotic tissue, exudate, epithelialization, and periwound skin condition. Secondary outcomes included: Wagner Scale (degree of foot involvement), Fontaine and Rutherford classifications (degree of ischemia), Nursing Outcomes Classification (NOC) (skin integrity), and the Diabetes-21 instrument (quality of life analysis). Results showed that the aPDT group experienced a significant reduction in clinical BJ scores starting from the fifth session (p = 0.002), with improvement maintained up to 30 days post-treatment. This evolution indicated more effective and accelerated tissue repair in the experimental group. Other clinical scales also showed significant improvements only in the aPDT group (p < 0.001), especially regarding ischemic status, epithelialization, and skin integrity. No deterioration was observed in any of the outcomes in the control group. Conclusion: Antimicrobial photodynamic therapy (aPDT) proved to be an effective and safe strategy for treating diabetic foot ulcers, promoting significant short-term improvements in wound quality and tissue repair.