Diabetic foot (DF) disease—including ulcerations, amputations, and infections—is a leading source of morbidity and mortality among people with diabetes mellitus (DM). Despite its clinical, social, and economic burden, global epidemiological estimates have been limited by fragmented evidence and heterogeneous study methods. This systematic review and meta-analysis aimed to produce pooled incidence and prevalence estimates of DF disease, to explore geographic and demographic variations, and to assess the types of data sources used in epidemiological research. The review was conducted following PRISMA guidelines and registered in PROSPERO (CRD42025640944).
A systematic search of PubMed, Embase, CINAHL Plus, and the Cochrane Library was performed from database inception to December 21, 2024. The review included observational studies of adults (≥18 years) with diabetes that reported epidemiological measures of DF disease. Four reviewers independently conducted data extraction and quality appraisal using Joanna Briggs Institute checklists. Random-effects meta-analyses were implemented with generalized linear mixed-effects models to calculate pooled complication-specific incidence and prevalence rates among patients with diabetes. Between-study heterogeneity was assessed using Cochran's Q, the I2 statistic, and τ2. Meta-regression analyses examined study-level covariates as potential modifiers of pooled estimates.
Eighty-nine studies met inclusion criteria: 18 prospective cohort studies, 33 retrospective cohorts, and 38 cross-sectional studies. Individual study sample sizes varied widely, from 92 to 29,650,811 participants. Geographic representation included Europe (29 studies, 32.6%), Asia (25, 28.1%), Africa (16, 18.0%), America (16, 18.0%), and Oceania (3, 3.4%). The included studies used diverse data sources and identification methods for DF conditions, contributing to methodological heterogeneity across the literature.
Using random-effects models, pooled global incidence rates among people with diabetes were calculated for major DF complications. The pooled incidence rates reported were:
These incidence estimates reflect the aggregated findings across studies with varying designs, settings, and follow-up durations.
Pooled global prevalence estimates among people with diabetes were also derived. The pooled prevalence measures were:
As with the incidence estimates, prevalence results pooled data from cross-sectional and cohort studies with heterogeneous measurement approaches.
Substantial heterogeneity was observed across pooled estimates, with I2 values exceeding 90% for most outcomes. Meta-regression identified several significant modifiers that partly explained between-study variability: geographic region, the method used to identify diabetic foot cases, type of data source, study setting, participant age, diabetes duration, and length of follow-up. These findings indicate that methodological choices and population characteristics materially affect reported DF epidemiology.
Regional patterns emerged in pooled analyses. Studies from America and Africa generally reported incidence and prevalence rates above the global pooled averages, whereas studies from Europe, Asia, and Oceania tended to report rates below the pooled averages. The review highlighted that demographic factors (such as age and diabetes duration) and differences in health systems and data capture likely contribute to these regional differences.
The pooled incidence and prevalence estimates confirm that DF disease is common and severe on a global scale, supporting its recognition as an important public health priority among people with diabetes. The identified heterogeneity underscores the need for standardized case definitions and harmonized data collection methods to improve comparability across studies. For pharmacoepidemiological research and intervention evaluation, the findings suggest that future studies should account for geographic and methodological modifiers and may benefit from large-scale, standardized data sources to monitor trends and assess the impact of preventive and therapeutic strategies.
The review documented marked heterogeneity across included studies, driven by differences in study design, case identification methods, data sources, and population characteristics. While meta-regression identified several modifiers, substantial unexplained variability remained. The review is limited to information reported in the included studies; details beyond what was presented in source reports were not available. Geographic coverage was uneven, with fewer studies from Oceania and variable representation across regions.
Globally, diabetic foot disease—including ulcerations, amputations, and infections—is common and severe among people with diabetes. Pooled incidence and prevalence estimates provided by this systematic review and meta-analysis quantify the global burden but are affected by substantial heterogeneity related to geography, methodology, and data sources. These results can inform future clinical, epidemiological, and pharmacoepidemiological studies aimed at evaluating interventions and monitoring temporal trends using large-scale datasets.