Leg Ischaemia Management Collaboration

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-110
SponsorUniversity of Leicester

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

420 Participants
are grouped into 5 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