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.
How this trial compares with your answers
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What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
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
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
Where Is This Study? (1 UK site)
Glenfield Hospital Leicester
Leicester LE3 9QP, United Kingdom
How to Get in Touch
Rob D Sayers, MD
Sponsor contactCONTACT
Tanya J Payne, BSc
Sponsor contactCONTACT
