About this trial
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
Eligibility criteria
Qualifiers
All patients presenting to the Leicester Vascular Institute with SLI
Disqualifiers
SLI not caused by PAOD
Patients undergoing intervention during their index presentation prior to recruitment
Patients lacking capacity to consent with no accompanying next of kin, relative, partner or friend who can act as a personal consulted
Patients who cannot read, write or understand English
Trial design
Treatments tested in this trial
- Not listed
Trial groups
Sponsors and collaborators
University of Leicester
Lead sponsor
University Hospitals, Leicester
Collaborator
National Institute for Health Research, United Kingdom
Collaborator
The George Davies Charitable Trust
Collaborator