BACKGROUND:People with diabetes have low health literacy, but the role of the latter in diabetic foot disease is unclear. AIM:To determine, through a systematic review and meta-analysis, if health literacy is associated with diabetic foot disease, its risk factors, or foot care. METHODS:We searched PubMed, EMBASE, CINAHL, Web of Science, Scopus and Science Direct. All studies were screened and data extracted by two independent reviewers. Studies in English with valid and reliable measures of health literacy and published tests of association were included. Data were extracted on the associations between the outcomes and health literacy. Meta-analyses were performed using random effects models. RESULTS:Sixteen articles were included in the systematic review, with 11 in the meta-analysis. In people with inadequate health literacy, the odds of having diabetic foot disease were twice those in people with adequate health literacy, but this was not statistically significant [odds ratio 1.99 (95% CI 0.83, 4.78); two studies in 1278 participants]. There was no statistically significant difference in health literacy levels between people with and without peripheral neuropathy [standardized mean difference -0.14 (95% CI -0.47, 0.18); two studies in 399 participants]. There was no association between health literacy and foot care [correlation coefficient 0.01 (95% CI -0.07, 0.10); seven studies in 1033 participants]. CONCLUSIONS:There were insufficient data to exclude associations between health literacy and diabetic foot disease and its risk factors, but health literacy appears unlikely to have a role in foot care. The contribution of low health literacy to diabetic foot disease requires definitive assessment through robust longitudinal studies.