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Risk factors for foot ulceration in adults with end-stage renal disease on dialysis: study protocol for a prospective observational cohort study

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posted on 2021-05-26, 06:05 authored by Michelle KaminskiMichelle Kaminski, Anita RaspovicAnita Raspovic, LP McMahon, Bircan ErbasBircan Erbas, Karl LandorfKarl Landorf
Background: Adults with end-stage renal disease treated with dialysis experience a high burden of foot ulceration and lower extremity amputation. However, the risk factors for foot ulceration in the dialysis population are incompletely understood due to the lack of high-quality prospective evidence. This article outlines the design of a prospective observational cohort study, which aims to investigate the risk factors for foot ulceration in adults on dialysis. Methods/Design: This study will recruit 430 participants with end-stage renal disease on dialysis from satellite and home-therapy dialysis units across multiple health organisations in Melbourne, Victoria, Australia. Data collection at baseline will include a participant interview, medical record review, completion of a health-status questionnaire and a non-invasive foot assessment. Twenty participants will also be recruited to a reliability study to evaluate the reproducibility of testing procedures. Primary outcome data includes: new foot ulcer(s). Secondary outcome data includes: number of new foot ulcers, time to onset of new foot ulcer(s), new lower extremity amputation(s), episodes of infection of the foot or lower extremity, episodes of osteomyelitis, foot-related hospitalisations, revascularisation procedure(s) of the lower extremity, new podiatry interventions, kidney transplantation, and mortality. Participants will be assessed at baseline, and at 12 months they will be evaluated for the primary and secondary outcomes. Multivariate Cox proportional hazards models will be used to assess predictors of new foot ulceration and time to event secondary outcomes. Logistic regression will be used for binary outcomes including prevalence of foot ulcerations. Discussion: This is the first multi-centre prospective observational cohort study to investigate risk factors for foot ulceration in adults with end-stage renal disease on dialysis. This study will improve on prior studies by using prospective methods, multi-centre recruitment, statistical methods to control for confounding variables, and a pre-specified sample size estimation. The findings can inform the design of future trials evaluating the effectiveness of clinical interventions, which may lead to improved patient outcomes in the dialysis setting.


M.R.K. receives an Australian National Health and Medical Research Council postgraduate scholarship (GNT1056105). The Eastern Health Podiatry Department is supplying the majority of equipment for use in the study. Consumables and some equipment have been donated by Briggate Medical Company (Victoria, Australia). The SF-36v2 (R) user licence and analysis software have been donated by Optum Incorporated (formally known as QualityMetric Incorporated). The FootMat (TM) 7.0 user licence and analysis software have been donated by Tekscan (Tekscan Inc, South Boston, MA, USA). The authors would like to acknowledge Eastern Health, Austin Health, Monash Health, Briggate Medical Company, Optum Incorporated and Tekscan for their support of the project.


Publication Date



Journal of Foot and Ankle Research





Article Number



17p. (p. 1-17)


BioMed Central



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