Peripheral Arterial DiseaseLIMbNCT04027244
Leg Ischaemia Management Collaboration
An observational study of Peripheral Arterial Disease and Critical Limb Ischemia, run by University of Leicester at 1 site in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 110 years
- Conditions the study is for
- Peripheral Arterial Disease, Critical Limb Ischemia, Frailty
- How many people
- 420 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 10 May 2019to 9 May 2031
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 110 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: As representative a sample of patients presenting to the Leicester Vascular Institute with SLI during the study period as possible. All patients presenting with SLI within the age criteria will be eligible and personal consultee consent will allow recruitment even of those patients lacking capacity to consent.
Who may be able to join
- 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 join
- 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
Show all 14Show fewer
- 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)
- 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
- Nil additional
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
Glenfield Hospital Leicester
Leicester, Leicestershire, LE3 9QP
Tanya J Payne, +44 (0)116 358 3867, tjp28@le.ac.uk
Rob D Sayers, MD
About this study
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:
Read more
- 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
Read the detailed description
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.
- Conditions
- Peripheral Arterial Disease, Critical Limb Ischemia, Frailty, Cognitive Impairment, Coronary Artery Disease
- Keywords
- Peripheral arterial disease, Limb salvage, Frailty, Cognitive dysfunction, Myocardial perfusion imaging, Biomarkers
- Medical subject headings
- Peripheral Arterial Disease, Chronic Limb-Threatening Ischemia, Frailty, Cognitive Dysfunction, Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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). |
What is being measured
The primary outcome is the main question the study is designed to answer.
12 month amputation rate
Proportion of patients undergoing major lower limb amputation
Measured: 12 months post recruitment
Secondary outcomes (6)
Amputation free survival
Composite outcome measure of death or amputation
Measured: ≥12 months post recruitment
All-cause mortality
Death from any cause
Measured: ≥12 months
Quality of life
Quality of life as measured by the Vascular Quality of Life questionnaire (VascuQoL)
- 25 item questionnaire, score 1-7 for each item, higher score = better quality of life
- Domains: activities (8 items), symptoms (4 items), pain (4 items), social (2 items) and emotional (7 items); each scored 1-7 (total of domain item scores/number of items)
- Overall score 1-7 (total item score/25)
Measured: 12 and 24 months post recruitment
Disability
Level of disability as measured by the Barthel Index
- Score 0-20; higher score = greater degree of functional independence/lower level of disability
Measured: 12 and 24 months post recruitment
Clinical Frailty Scale
Prevalence and degree of frailty as measured by the Clinical Frailty Scale (CFS)
- Score 1-9, higher score = greater degree of frailty
- Results will also be reported dichotomised to frail (score ≥5) and non-frail (score ≤4)
Measured: Baseline, 12 and 24 months
Anxiety & Depression
Prevalence and degree of anxiety and depression as measured by the Hospital Anxiety and Depression Scale (HADS)
- 14 item questionnaire; score 0-3 for each item, higher score = more severe anxiety/depression
- Domains: Depression (7 items), Anxiety (7 items); each scored 0-21; 0-7 = normal, 8-10 = bordeline, 11-21 = abnormal (case).
Measured: Baseline, 12 and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2019
- Study start10 May 2019
- Primary completion9 May 2022 (estimated)
- Study completion9 May 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Peripheral Arterial DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 420 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Leicester
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospitals, Leicester, National Institute for Health Research, United Kingdom, The George Davies Charitable Trust
- Responsible party
- Sponsor
- Investigators
- Rob D Sayers, MD, Study chair, University of Leicester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04027244
- Sponsor's protocol ID
- 0686
- Acronym
- LIMb
- Status last verified
- Nov 2020
- First submitted
- 11 Jul 2019
- Last updated
- 4 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Anonymised dataset will be available on request to the Chief Investigator (Prof Rob Sayers). The study protocol will be published in an open-access journal prior to completion of recruitment.
Publications
Houghton JSM, Nduwayo S, Nickinson ATO, Payne TJ, Sterland S, Nath M, Gray LJ, McMahon GS, Rayt HS, Singh SJ, Robinson TG, Conroy SP, Haunton VJ, McCann GP, Bown MJ, Davies RSM, Sayers RD. Leg ischaemia management collaboration (LIMb): study protocol for a prospective cohort study at a single UK centre. BMJ Open. 2019 Sep 3;9(9):e031257. doi: 10.1136/bmjopen-2019-031257.
PubMed 31481569
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Leg Ischaemia Management Collaboration
- ClinicalTrials.gov ID
- NCT04027244
- Acronym / sponsor ID
- LIMb / 0686
- Conditions
- Peripheral Arterial Disease, Critical Limb Ischemia, Frailty, Cognitive Impairment, Coronary Artery Disease
- Keywords
- Peripheral arterial disease, Limb salvage, Frailty, Cognitive dysfunction, Myocardial perfusion imaging, Biomarkers
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 420 participants (estimated)
- Lead sponsor
- University of LeicesterUniversity, hospital or other
- Collaborators
- University Hospitals, Leicester, National Institute for Health Research, United Kingdom, The George Davies Charitable Trust
- Study start
- 10 May 2019 (actual)
- Primary completion
- 9 May 2022 (estimated)
- Study completion
- 9 May 2031 (estimated)
- First posted
- 19 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 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). |
Who may qualify
- Ages
- 18 to 110 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- As representative a sample of patients presenting to the Leicester Vascular Institute with SLI during the study period as possible. All patients presenting with SLI within the age criteria will be eligible and personal consultee consent will allow recruitment even of those patients lacking capacity to consent.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
12 month amputation rate
Time frame: 12 months post recruitment
Proportion of patients undergoing major lower limb amputation
6 secondary outcomes
Amputation free survival
Time frame: ≥12 months post recruitment
All-cause mortality
Time frame: ≥12 months
Quality of life
Time frame: 12 and 24 months post recruitment
Disability
Time frame: 12 and 24 months post recruitment
Clinical Frailty Scale
Time frame: Baseline, 12 and 24 months
Anxiety & Depression
Time frame: Baseline, 12 and 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2020.
- Derived from this study: PubMed 31481569Houghton JSM, Nduwayo S, Nickinson ATO, Payne TJ, Sterland S, Nath M, Gray LJ, McMahon GS, Rayt HS, Singh SJ, Robinson TG, Conroy SP, Haunton VJ, McCann GP, Bown MJ, Davies RSM, Sayers RD. Leg ischaemia management collaboration (LIMb): study protocol for a prospective cohort study at a single UK centre. BMJ Open. 2019 Sep 3;9(9):e031257. doi: 10.1136/bmjopen-2019-031257.
- Individual participant dataSharing planned: Undecided. Anonymised dataset will be available on request to the Chief Investigator (Prof Rob Sayers). The study protocol will be published in an open-access journal prior to completion of recruitment.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Rob D Sayers, MD study chair
University of Leicester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Peripheral Arterial Disease and Critical Limb Ischemia, run by University of Leicester at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rob D Sayers, MD (+44 (0)116 252 3141, rs152@le.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
12 month amputation rate (time frame: 12 months post recruitment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04027244, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2020; AzTrials last refreshed its copy on 26 Oct 2026.