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Leg Ischaemia Management Collaboration

Sponsor: University of Leicester

NCT ID: NCT04027244

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Health checks and monitoring — no treatment given
Type of study
Observational (no treatment given)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Not specified by the sponsor
How long the study runs
Study runs about 144 months (dates as stated)
About the drug or intervention
Not specified by the sponsor
Patient visit burden
Not specified by the sponsor
Type of study
Observing health over time
Ages
18 Years to 110 Years
Who
All
Number of participants
420
Started
2019-05-10
Last checked
2020-11

Plain English Summary

What is this study?

  • • Testing a new treatment for peripheral arterial disease
  • • Clinical study - 420 participants
  • • Single-centre prospective cohort study of patients presenting with severe limb ischaemia (SLI)

Who can take part?

  • • Ages 18 Years to 110 Years
  • • Diagnosed with peripheral arterial disease

Where?

  • • Leicester - Glenfield Hospital Leicester

This is a simplified summary. Always discuss with your doctor before making any decisions.

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

More detail

Severe limb ischaemia (SLI) is the end-stage of peripheral arterial occlusive disease (PAOD) whereby the viability of the limb is threatened due to the degree of arterial disease and subsequent ischaemia in the peripheral tissues. It is defined as ischaemic rest pain (or night pain) and/or ulceration or gangrene in the affected limb(s) for a minimum of two weeks attributed to confirmed PAOD. Treatment includes open surgical and endovascular revascularisation, with or without surgical debridement of affected tissues, amputation of toes and drainage of sepsis. In some patients revascularisation is not possible or fails resulting in the person requiring a major lower limb amputation. Over 4000 major lower limb amputations per year were undertaken in England alone between 2003 and 2013 and a diabetes-related major lower limb amputation is performed every 30 seconds world-wide. As many as 25% of people with SLI will undergo a major lower limb amputation in the first year after presentation. Amputation negatively affects quality of life due to its negative impact on mobility, independence and ability to carry out activities of daily living. This single-centre prospective cohort study will investigate the amputation rate at one year in patients presenting with SLI and compare this to a retrospectively identified historical cohort. This study will also investigate the prevelance and degree of frailty, cognitive impairment, and cardiac disease (detected by cardiac magnetic resonance imaging (MRI)), as well as establish a biobank for future biomarker analyses. The role of frailty and cognitive assessments, cardiac MRI and biomarker analysis in risk-stratifying patients with SLI will also be investigated.

Peripheral Arterial DiseaseCritical Limb IschemiaFrailtyCognitive ImpairmentCoronary Artery Disease

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What we know so far

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Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years - 110 Years
  • Who can join: All genders

Biomarkers mentioned

eGFR

What the study is looking for

  • ✓All patients presenting to the Leicester Vascular Institute with SLI

Who cannot take part

  • ✗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...
  • ✗Patients who cannot read, write or understand English
  • ✗FRAILTY \& COGNITIVE ADDITIONAL ASSESSMENTS
See the full 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 Is This Study? (1 UK site)

Glenfield Hospital Leicester

Leicester LE3 9QP, United Kingdom

Recruiting
Site contact (verified)
Rob D Sayers, MDPrincipal Investigator

How to Get in Touch

Rob D Sayers, MD

Sponsor contact

CONTACT

+44 (0)116 252 3141 rs152@le.ac.uk

Tanya J Payne, BSc

Sponsor contact

CONTACT

+44 (0)116 258 3867 tjp28@le.ac.uk
Data sourced from ClinicalTrials.gov · Last verified: 2020-11