Leg ischaemia management collaboration (LIMb): study protocol for a prospective cohort study at a single UK centre.
John S M Houghton, Sarah Nduwayo, Andrew T O Nickinson...
https://pubmed.ncbi.nlm.nih.gov/31481569Actively Recruiting
Age: 18Years - 110Years
All Genders
ID04027244
Leg Ischaemia Management Collaboration
Led by University of Leicester · Updated on 2020-11-04
420
Participants Needed
1
Research Sites
469 weeks
Total Duration
On this page
Sponsors
U
University of Leicester
Lead Sponsor
U
University Hospitals, Leicester
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are investigating severe limb ischaemia (SLI), a serious stage of peripheral arterial disease where blood flow to the limbs is severely reduced, causing pain, ulcers, or gangrene lasting at least two weeks. This study aims to determine how many patients undergo major lower limb amputation within 12 months and to compare outcomes to a past group of patients. It also examines frailty, cognitive impairment, heart disease through cardiac MRI, and collects samples for future biomarker studies to improve risk assessment of SLI patients. The study follows patients presenting with SLI at a vascular institute over two years, including those undergoing interventions for their condition. Various assessments are done such as frailty and cognitive tests for older patients, cardiac MRI scans for heart disease evaluation, and biomarker collection for research. A historical group of patients treated between 2013 and 2015 is used for comparison. Participants will be monitored for up to two years with evaluations of amputation rates, survival without amputation, general mortality, quality of life, disability, frailty, anxiety, and depression. Data collection includes clinical exams, questionnaires, imaging, and biomarker analysis. The study aims to improve understanding of outcomes and risk factors in SLI and supports long-term patient follow-up.
CONDITIONS
Brief Title
Leg Ischaemia Management Collaboration
Who Can Participate
Age: 18Years - 110Years
All Genders
Eligibility Criteria
You may qualify if you...
- All patients presenting to the Leicester Vascular Institute with severe limb ischaemia (SLI)
- Patients aged 65 years or older undergoing an intervention for SLI (for frailty and cognitive assessments)
- Patients undergoing an intervention for SLI (for cardiac MRI and biomarker assessments)
You will not qualify if you...
- SLI not caused by peripheral arterial occlusive disease
- Patients having intervention for SLI before recruitment
- Patients unable to consent with no personal consultee available
- Patients who cannot read, write, or understand English
- Any serious illness that risks patient safety or affects study results
- Contraindications to cardiac MRI such as pregnancy, certain implants, severe claustrophobia, unstable angina
- Known adverse reaction to gadolinium contrast or severe kidney failure (for cardiac MRI)
- Patients lacking capacity to consent for cardiac MRI
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Monitoring
Duration - 12 months to 2 years
Participants presenting with severe limb ischaemia are observed to investigate amputation rates, prevalence of frailty, cognitive impairment, cardiac disease, and biomarker analyses over time.
Assessments at baseline, 12 months, and 24 months
Trial Site Locations
Total: 1 location
1
Glenfield Hospital Leicester
Leicester, Leicestershire, United Kingdom, LE3 9QP
Actively Recruiting
Loading map...
Research Team
R
Rob D Sayers, MD
T
Tanya J Payne, BSc
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
5
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here