Early access
Sign in
Taking people in United KingdomNo phase

Following people with severe leg circulation problems to see if they need amputation

Follows adults with severe limb ischaemia to track whether major leg amputation occurs.

Key facts

Who runs it
University of Leicester
Where
Leicester, United KingdomSee the site
Trial code
Registry title
Leg Ischaemia Management Collaboration
Status
Recruiting
People taking part
420 people, planned
Started
10 May 2019
Expected to end
9 May 2031
Type of study
Observational, 5 groups
Record updated
4 November 2020

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults who come to the Leicester Vascular Institute with severe limb ischaemia (poor blood flow to the leg) caused by narrowed leg arteries. Some extra tests are for those who will have a procedure.

Age
18 to 110 years. The extra frailty and thinking tests are for people aged 65 or older.
Sex
All sexes can join.
Disease stage
Severe limb ischaemia caused by peripheral arterial occlusive disease (PAOD). Extra tests are for people who have decided to have an intervention.
Earlier treatment
People who already had an intervention during this first visit, before joining, cannot join.

Main reasons for not taking part

  • Severe limb ischaemia not caused by PAOD
  • Had an intervention during the first visit, before joining
  • Cannot give consent and has no relative or friend to act as a consultee
  • Cannot read, write or understand English
  • Cardiac MRI part: cannot have the MRI scan or the gadolinium contrast agent, for example pacemaker, severe claustrophobia, eGFR <30mL/min/1.73m^2

The registry criteria, word for word

Show all 16 criteriaShow less

Who can take part

  • All patients presenting to the Leicester Vascular Institute with SLI
  • Patients recruited to the primary cohort in whom a decision has been made to undergo an intervention for SLI
  • Patients aged ≥65 years
  • Patients recruited to the primary cohort in whom a decision has been made to undergo an intervention

Who cannot take part

  • Patients undergoing intervention during their index presentation prior to recruitment
  • 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
  • Nil additional; CARDIAC MRI ADDITIONAL ASSESSMENTS
  • 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)
  • Patients lacking capacity to consent for cardiac MRI; BIOMARKERS ADDITIONAL ASSESSMENTS
  • Contraindication to gadolinium contrast agent (Known adverse reaction, chronic renal failure (eGFR <30mL/min/1.73m\^2))
  • SLI not caused by PAOD
  • 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
  • Patients recruited to the primary cohort in whom a decision has been made to undergo an intervention
  • Nil additional

Other criteria

  • PRIMARY COHORT

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 18 and 110 years old?

Where in United Kingdom

  • Glenfield Hospital LeicesterLeicester, United KingdomContact: Tanya J PayneTaking people

About the trial

What the trial wants to find out

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.

Read full original descriptionShow less

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

The 5 groups in the trial

  • Primary cohort

    Any patient presenting to the Leicester Vascular Institute with SLI during the 2 year recruitment period (minimum 420 patients).

  • Frailty & cognitive additional assessments

    Any patient recruited to the primary cohort aged ≥65 years and undergoing an intervention for SLI (minimum 150 patients, target 210 patients).

  • Cardiac MRI additional assessments

    Any patient recruited to the primary cohort, with capacity to consent and undergoing an intervention for SLI (minimum 100 patients).

  • Biomarkers additional assessments

    Any patient recruited to the primary cohort and undergoing an intervention for SLI (no target recruitment set).

  • Historical cohort

    Retrospectively identified cohort of patients presenting to the study site with SLI between 2013 -15 (target 420).

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Leg Ischaemia Management Collaboration
Plain-language title
Following people with severe leg circulation problems to see if they need amputationGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Fit questions
Built from NCT04027244, who can take part
Record updated
4 November 2020