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Leg Ischaemia Management Collaboration

NCT04027244 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 420

Last updated 2020-11-04

No results posted yet for this study

Summary

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

Conditions

Sponsors & Collaborators

  • University Hospitals, Leicester

    collaborator OTHER

  • National Institute for Health Research, United Kingdom

    collaborator OTHER_GOV

  • The George Davies Charitable Trust

    collaborator UNKNOWN

  • University of Leicester

    lead OTHER

Principal Investigators

  • Rob D Sayers, MD · University of Leicester

Eligibility

Min Age
18 Years
Max Age
110 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-05-10
Primary Completion
2022-05-09
Completion
2031-05-09

Countries

  • United Kingdom

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04027244 on ClinicalTrials.gov