O uso da fotobiomodulação e terapia fotodinâmica antimicrobiana no tratamento de úlceras do pé relacionadas ao diabetes: overview de revisões sistemáticas e consenso pelo método Delphi modificado

Abstract

Diabetes-related foot ulcers constitute one of the most serious and disabling chronic complications of diabetes mellitus, being associated with reduced quality of life, increased risk of amputations, and high morbidity and mortality rates. The healing process of these lesions is often compromised by metabolic and pathophysiological alterations resulting from chronic hyperglycaemia, including persistent inflammation, oxidative stress, microvascular dysfunction, peripheral neuropathy, and increased susceptibility to infections—factors that impair tissue repair and limit the response to conventional treatments. In this context, light-based therapies, such as photobiomodulation (PBM) and antimicrobial photodynamic therapy (aPDT), have been investigated as promising adjunctive therapeutic strategies in the management of these lesions. Scientific evidence suggests that these approaches may favour the wound healing process by modulating the inflammatory response, stimulating angiogenesis, cell proliferation, and collagen synthesis, in addition to contributing to local infection control, reducing the microbial load and biofilm, thereby enhancing tissue repair and clinical recovery of the lesions. This study aimed to develop an expert consensus, based on the best available evidence, regarding the use of PBM and aPDT in the treatment of diabetes-related foot ulcers. This is a methodological study conducted in two complementary stages. Initially, an umbrella review of systematic reviews and meta-analyses was conducted, following PRISMA recommendations and prospectively registered on the PROSPERO platform under number CRD42024589660. Searches were performed in the MEDLINE/PubMed, EMBASE, and LILACS databases, including systematic reviews, meta-analyses, guidelines, and consensus statements that evaluated the effects of PBM and aPDT on diabetes-related foot ulcers. Outcomes related to tissue repair, dosimetric parameters, safety, and adverse events were analysed. In the second stage, the review findings were submitted to an interdisciplinary panel of 20 national and international experts, selected for their expertise in the fields of biophotonics, diabetes, stoma therapy, and podiatry. The consensus was conducted using a modified Delphi technique, over two anonymous rounds administered via an electronic form, employing a Likert scale structured into four response categories. A minimum agreement level of 75% was pre-established to define consensus. Data analysis was performed descriptively and qualitatively through a narrative synthesis of the findings. The methodological quality of the included studies was assessed using the AMSTAR 2 and AGREE II instruments, while the certainty of the evidence and the strength of the available evidence were classified based on the GRADE system. The results of all selected reviews and meta-analyses demonstrated that PBM had positive effects on tissue repair, including accelerated healing and a higher probability of complete closure. aPDT demonstrated relevant potential in reducing the microbial load and consequently improving local tissue repair. Regarding safety, no serious short-term adverse events were identified for either therapy, although mild adverse events were described for aPDT, and studies lacked medium- and long-term assessments. Despite favourable findings, significant methodological heterogeneity was observed among primary studies, particularly concerning dosimetric parameters, biases, small sample sizes, subjective analyses, and the therapeutic protocols employed, which impacted the GRADE analysis. The expert consensus reinforced that both therapies should be used exclusively as adjunctive approaches to standard care. Although definitive consensus on the ideal therapeutic parameters was not established, recommendations regarding indications, monitoring parameters, and dosimetric ranges potentially favourable to tissue repair and clinical lesion management were suggested. Although the available results demonstrate relevant clinical benefits, more robust clinical trials with larger sample sizes, multicentre designs, standardised protocols, and methodological consistency are still needed to strengthen the quality of the evidence and consolidate reproducible therapeutic protocols for the use of PBM and aPDT in the treatment of diabetes-related foot ulcers. The development of comparative studies on dosimetry and parameters is also urgently needed.