Management of severe limb ischaemia and its outcomes
Official title: Leg Ischaemia Management Collaboration
Run by University of Leicester · NCT04027244 · Data updated 2026-11-12
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 |
|---|---|
| Ages | 18 Years to 110 Years |
| Sex | All |
| Enrollment | 420 (estimated) |
| Sponsor | University of Leicester Academic / other |
| Locations | 1 site (Leicester, Leicestershire) |
| Status | Recruiting |
| Started | May 10, 2019 |
| Main results expected | May 9, 2022 |
| Study ends | May 9, 2031 |
| Registry record updated | November 4, 2020 |
| Trial ID | NCT04027244 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include patients presenting with severe limb ischaemia due to peripheral arterial occlusive disease.
✕Probably not a fit
Patients whose severe limb ischaemia is not caused by peripheral arterial occlusive disease may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: While studies on limb ischaemia exist, this specific approach focusing on a rapid-access limb salvage clinic and comprehensive assessments is relatively novel.
Who can join: the full rules
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 it's running
-
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
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Radial and Ulnar Access in Vascular Interventions Registry
This registry tests how often radial or ulnar artery access is used and what happens afterward in routine vascular procedures.
-
Preoperative cognitive screening and postoperative delirium in older adults undergoing hip replacement
This study tests whether a brief preoperative cognitive screen (ALBA) can predict delirium within 72 hours after hip replacement in older adults.
-
Survey on disability and cognitive impairment in elderly people in Beijing
This study is trying to find out what factors might lead to disability and memory problems in older adults living in Beijing, so they can help prevent these issues in the future.
-
Assessing visual frailty in older adults with age-related macular degeneration
This study is trying to see if a new tool can help understand how vision problems affect older adults with advanced age-related macular degeneration and their overall health.
-
Assessing temperature changes in legs before and after vascular procedures
This study is testing if measuring leg temperatures with a thermal camera before and after surgery can help predict how well patients with peripheral arterial disease will do after their procedures.
-
Comparing enteric-coated and plain aspirin to reduce heart disease risks from air pollution
This study is testing whether enteric-coated or plain low-dose aspirin can better help people with heart disease reduce their risks from air pollution, along with providing tips to stay healthy.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.