Regional Assessment of Lower limb Amputations in sub-Saharan Africa (RAMPs): a prospective cohort study protocol

Major lower limb amputation, defined as an amputation above the level of the ankle joint, is a substantial cause of morbidity and mortality. Limited data exist on the burden, aetiology and outcomes of major lower limb amputations in sub-Saharan Africa (SSA). This is despite increasing rates of diabetes, peripheral arterial disease and trauma, with further projected increases in these conditions, which often precede major lower limb amputation. The Regional Assessment of Amputations in sub-Saharan Africa (RAMPs) study aims to address this knowledge gap by performing a multicentre, prospective study of major lower limb amputations across the region.

We describe a prospective, multicentre observational cohort study enrolling patients undergoing major lower limb amputation at hospitals in SSA over a consecutive 6-month period. Consecutive patients will be included, and data will be collected from medical records until discharge, death or 30 days postoperatively, whichever is sooner. The primary outcome is in-hospital or 30-day mortality. Secondary outcomes include the aetiology of amputations and in-hospital complications. We will also examine systems and processes using a facility survey of each participating centre. The study will collect system-level, patient-level and outcome-level data. Our sample size calculation suggests 904 patients need to be recruited.

The RAMPs study will provide a snapshot of the current outcomes and aetiology of major lower limb amputation in SSA. It will show if variation in outcomes and aetiology in patients in the region exists and provide information on the healthcare processes and systems in those who may be at risk of lower limb amputation. Ethical approval has been granted by the University of Birmingham (Science, Technology, Engineering and Mathematics Committee reference: ERN_2929-Jan2025) and the College of Surgeons of East, Central and Southern Africa (COSECSA Institutional review board reference COSECSA/REC/2025/07). Findings will be disseminated throughout the region at local, national and international conferences and through at least one peer-reviewed manuscript.