Aim: Health literacy (HL) is the concept of cognitive and social skills determining the motivation and ability of individuals to access, understand and use health information. People with diabetes have low HL(1)to the detriment of self-care and glycemic control. As such, HL is imperative for people with diabetes to prevent complications like diabetic foot disease (DFD). This systematic review aims to synthesize all evidence on associations between HL and DFD or foot care in people with diabetes.

Methods: A bibliographical search of PubMed, EMBASE, CINAHL, Web of Science, Scopus and Science Direct has been performed using terms for diabetes, HL and DFD outcomes. Studies published in English with valid and reliable measures of HL and foot outcomes in people with diabetes will be considered for inclusion. Two reviewers will independently assess identified references against these criteria, and perform data extraction and assessment of methodological quality of included studies using criteria published for use in observational studies, modified to suit the content of this review. Data to be extracted will include study and participant characteristics; and data quantifying associations between HL and primary outcomes of DFD (amputation, foot ulceration, infection or ischemia), or secondary outcomes of DFD risk factors (peripheral neuropathy, peripheral arterial disease and foot deformity) and foot self-care behavior. The protocol is registered with the international prospective register of systematic reviews.

Results: The bibliographical search identified 88 articles relevant to the research question. Study findings will be presented as odds ratios or risk factors for primary outcomes and standardized mean differences for secondary outcomes. The chi-squared and I-squared tests will be used to quantify inconsistencies across studies.

Conclusions: This robust systematic review will provide a comprehensive synthesis of current evidence associating HL and foot outcomes in diabetes. These findings will inform the agenda for future research and positively influence clinicians’ approaches to patient communication around issues of foot care and prevention of DFD in people with diabetes.