Leg Ischaemia Management Collaboration

Single-centre prospective cohort study of patients presenting with severe limb ischaemia (SLI). The primary outcome measure will be 12 month major amputation rate. A historical cohort of patients identified retrospectively will be the comparitor group used to assess the impact of a newly-established rapid-access limb salvage clinic. Primary aim: \- Determine the proportion of patients with SLI undergoing major lower limb amputation within 12 months of presentation. Secondary aims: * Assess clinically important short-, medium- and long-term outcomes in those undergoing and not undergoing amputation * Prevalence and degree of frailty and cognitive impairment * Pevalence and degree of cardiac disease (detected by stress MRI) * Establish a biobank for future biomarker analysis * Investigate the role of frailty and cognitive assessments, cardiac MRI and biomarkers in risk-stratification of patients with SLI

NCT Number	NCT04027244
Lead Sponsor	University of Leicester Collaborators: University Hospitals, Leicester, National Institute for Health Research, United Kingdom, The George Davies Charitable Trust
Conditions	Peripheral Arterial Disease, Critical Limb Ischemia, Frailty, Cognitive Impairment, Coronary Artery Disease
Enrollment	420 participants
Start Date	2019-05-10
Primary Completion	2022-05-09 (estimated)
Study Completion	2031-05-09 (estimated)
Updated on ClinicalTrials.gov	2020-11-04