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.

Advancing equity, diversity and inclusion in health research trials is essential for improving health outcomes among priority populations. While evidence increasingly highlights the importance of cultural diversity in research trial leadership and participation, evidence-based strategies for enhancing this remain limited. This article outlines approaches to strengthen Aboriginal and Torres Strait Islander involvement in health research trials, drawing on insights from community engagement at the Darwin (Northern Territory) trial site of the Australian Fans in Training (Aussie-FIT) project.

Community engagement at this site aimed to (1) build mutually beneficial relationships with community leaders, specifically Aboriginal and Torres Strait Islander men; (2) codesign engagement standards to enhance the quality of engagement with these leaders and more broadly with local community members and stakeholders. A culturally diverse community advisory group was established, which codesigned engagement standards tailored to community needs and preferences.

While the codesigned standards supported Aboriginal and Torres Strait Islander trial leadership and participation during the trial, the extensive consultation needed to build cross-cultural relationships and develop the standards meant they were finalised only after trial recruitment had ceased. As a result, researchers were unable to fully implement them in the early stages of the trial.

This paper shared and critically discussed approaches used in the early stages of the Aussie-FIT trial to foster more equitable and inclusive practices in research trials. Implementation of these approaches and community-informed recommendations has the potential to enhance research quality, build trust with priority populations and address participation inequities, thus supporting effective trial design and improved health outcomes.

This trial is registered with the Australian New Zealand Clinical Trials Registry (ACTRN12623000437662).