Management of severe limb ischaemia and its outcomes
Leg Ischaemia Management Collaboration
This study looks at patients with severe limb ischaemia to see how often they need major amputations within a year and how factors like frailty and heart health affect their outcomes.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 420 (estimated) |
| Ages | 18 Years to 110 Years |
| Sex | All |
| Sponsor | University of Leicester Academic / other |
| Locations | 1 site (Leicester, Leicestershire) |
| Trial ID | NCT04027244 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on patients presenting with severe limb ischaemia (SLI) at the Leicester Vascular Institute. It aims to determine the rate of major lower limb amputations within 12 months of presentation and assess various outcomes related to frailty, cognitive impairment, and cardiac health. The study will compare results with a historical cohort and establish a biobank for future biomarker analysis. By investigating the interplay of these factors, the study seeks to improve risk stratification and management of patients with SLI.
Who should consider this trial
Good fit: Ideal candidates include patients presenting with severe limb ischaemia due to peripheral arterial occlusive disease.
Not a fit: Patients whose severe limb ischaemia is not caused by peripheral arterial occlusive disease may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved management strategies that reduce the need for amputations and enhance patient quality of life.
How similar studies have performed: While studies on limb ischaemia exist, this specific approach focusing on a rapid-access limb salvage clinic and comprehensive assessments is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
PRIMARY COHORT Inclusion Criteria: * All patients presenting to the Leicester Vascular Institute with SLI Exclusion Criteria: * 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 * Any significant disease or disorder which may either put the patient at risk because of participation in the study, or may influence the results of the study or the patient's ability to participate in the study FRAILTY \& COGNITIVE ADDITIONAL ASSESSMENTS Inclusion criteria: * Patients recruited to the primary cohort in whom a decision has been made to undergo an intervention for SLI * Patients aged ≥65 years Exclusion criteria: * Nil additional CARDIAC MRI ADDITIONAL ASSESSMENTS Inclusion criteria: * Patients recruited to the primary cohort in whom a decision has been made to undergo an intervention Exclusion criteria: * Absolute contraindications to cardiac MRI (Pregnancy, Non-MR safe permanent pacemaker, implanted cardiac defibrillator, intra-auricular implant or intra-cranial clips, severe claustrophobia, unstable angina) * Contraindication to gadolinium contrast agent (Known adverse reaction, chronic renal failure (eGFR \<30mL/min/1.73m\^2)) * Patients lacking capacity to consent for cardiac MRI BIOMARKERS ADDITIONAL ASSESSMENTS * Patients recruited to the primary cohort in whom a decision has been made to undergo an intervention Exclusion criteria: * Nil additional
Where this trial is running
Leicester, Leicestershire
- Glenfield Hospital Leicester — Leicester, Leicestershire, United Kingdom (Recruiting)
Study contacts
- Study coordinator: Rob D Sayers, MD
- Email: rs152@le.ac.uk
- Phone: +44 (0)116 252 3141
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.