The FraiLTI (Frailty in chronic Limb-Threatening Ischaemia) Protocol

Abstract

Background: Frailty, sarcopenia and multimorbidity are conditions commonly associated with the ageing process, and they are frequently observed in patients with chronic limb-threatening ischaemia (CLTI). Nevertheless, the extent to which these conditions are prevalent within the CLTI patient population has not been adequately examined in the UK. This proposed multicentre observational study aims to investigate the prevalence of these conditions in patients with CLTI and to assess their potential impact on important clinical outcomes including mortality, amputation and quality of life. Methods: FraiLTI (Frailty in chronic Limb-Threatening Ischaemia) is a multicentre prospective observational study in the UK that that aims to investigate the prevalence of frailty, sarcopenia and multimorbidity associated with CLTI. The secondary objective is to investigate potential correlations between frailty, sarcopenia and multimorbidity, with clinical outcomes such as amputation, mortality, major adverse cardiovascular events and readmission rates within a 90-day period. FraiLTI is led by Newcastle University, supported by the Vascular and Endovascular Research Network (VERN) and funded by the National Institute for Health Research (NIHR) and the Newcastle Hospital Charities. REDCap will be used to collect anonymised patient data. All hospitals with a dedicated vascular centre are eligible to participate. Full ethical approval (21/PR/0750) was granted on 13 July 2021. The study is registered on the International Standard Randomised Controlled Trial Number (ISRCTN) registry. Anticipated impact of the study: This study has the potential to address critical questions identified by the James–Lind Alliance (JLA) Priority Setting Partnership (PSP) in peripheral arterial disease. It is expected to make a substantial contribution to the creation of a prospective CLTI database, integrating essential data on frailty, sarcopenia and multimorbidity that are not currently captured by other registries, despite their profound impact on patient outcomes. This research could provide pivotal insights into the prevalence of frailty, sarcopenia and multimorbidity among the UK’s CLTI population and their corresponding effects on clinical outcomes. Findings from the study will be shared at global scientific conferences and submitted to be published in peer-reviewed journals.