What this means
Researchers will follow patients with severe leg blood flow problems for 12 months and count how many lose a leg. They will compare them with past patients, which may show whether a new fast-access clinic helps.
Plain-English summary written by an AI model from the registry listing.
- Status
- Recruiting
- Who can join
- Ages 18–110
- Where
- 1 site
The science
- Registered title
- Leg Ischaemia Management Collaboration
- Trial ID
- NCT04027244 ↗
- Phase
- Not applicable
- Study type
- observational
- Conditions
- Peripheral Arterial Disease, Critical Limb Ischemia, Frailty, Cognitive Impairment, Coronary Artery Disease
- Sponsor
- University of Leicester
- Ages
- 18 Years to 110 Years
- Dates
- First posted Jul 19, 2019 · updated Nov 4, 2020
Registry 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
Sites (1)
- Glenfield Hospital Leicester, Leicester, Leicestershire, United Kingdom