RecruitingOBSERVATIONAL

Leg Ischaemia Management Collaboration

This study, called "Leg Ischaemia Management Collaboration," is looking at how well a new clinic helps people with severe leg circulation problems, known as severe limb ischaemia. This is when poor blood flow threatens the leg. The main goal is to see how many patients need a major leg amputation within one year of first coming to the hospital. Researchers will compare patients treated by the new clinic to a group of patients treated before the clinic started. The study also aims to understand how conditions like frailty (being generally weak), memory problems, and heart disease affect these patients. The findings will help doctors better predict risks and provide the best care for people facing severe leg circulation issues.

At a glance

Status

Recruiting

Sponsor

University of Leicester

Enrolment target

420

Start

10 May 2019

Estimated completion

09 May 2031

Peripheral Arterial Disease Critical Limb Ischemia Frailty Cognitive Impairment Coronary Artery Disease

What is this study about?

This study focuses on a serious condition called severe limb ischaemia, where blood flow to the legs is very poor. This can cause pain, sores, or even tissue death, and in some cases, it can lead to a major leg amputation. This condition often affects people with peripheral arterial disease, which is when arteries in the legs narrow and harden. Amputations can significantly affect a person's life, making it harder to move around and live independently.

The main idea behind this study is to see if a newly established "rapid-access limb salvage clinic" helps reduce the number of major leg amputations. Researchers are looking at patients who come to the Leicester Vascular Institute with severe leg ischaemia. They will track these patients for one year to see how many need a major amputation. This number will then be compared to a group of similar patients who received care before the special clinic was available. This comparison will help doctors understand how effective the new clinic is.

Beyond just tracking amputations, the study also aims to understand other important factors. It will look at how common frailty (overall weakness), memory problems, and heart disease are in these patients. They will use special heart scans (MRI) to check for heart problems and also collect blood samples for future research. This will help doctors learn more about who is most at risk and how these other health issues might influence treatment and recovery.

Key takeaways

The study aims to improve care for very poor leg circulation (severe limb ischaemia).
It will compare a new specialist clinic's results to previous care.
The main goal is to see if major leg amputations are reduced within a year.
Researchers will also look at how frailty, memory, and heart health affect patients.
Participation involves observation and possibly some extra, consent-based health checks.
Your medical treatment will not be changed by joining the study.

Who may be eligible?

To be part of the main study group, you must be a patient coming to the Leicester Vascular Institute with severe leg ischaemia. This means you have very poor blood circulation in your legs that is threatening the limb. However, you can't join if your leg problem isn't caused by poor circulation in the arteries, or if you've already had surgery or a procedure for your leg problem before the study team can talk to you.

You also need to be able to fully understand and agree to take part in the study. If you can't give consent yourself, a close family member or friend might be able to do it for you as a 'personal consultee'. You also need to be able to read, write, and understand English. People with any other serious health problems that might make taking part risky or affect the study results would also not be able to join.

There are also additional parts of the study. For example, to check for frailty and memory, you need to be in the main study group, be aged 65 or older, and have had a decision made for you to have a treatment for your leg problem. For the heart scan (MRI), you also need to be in the main group and have a treatment planned, but you cannot have certain medical implants (like some pacemakers), severe claustrophobia, be pregnant, or have severe kidney problems that prevent you from having the special dye needed for the scan.

Quick self-check

Have I recently been diagnosed with severe leg circulation problems at Leicester Vascular Institute?
Is my leg problem caused by narrow arteries, not something else?
Have I had surgery or a procedure for my leg problem BEFORE being asked to join the study?
Can I understand English well enough to read and sign consent forms?
Do I have any severe heart problems or implants (like certain pacemakers) that would prevent an MRI if asked?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you are asked to join the main part of this study, you will be followed up for 12 months after your initial visit to the clinic. The main thing they will look at is whether you need a major leg amputation within that year. You won't be given any new medicines as part of this study, nor will your treatment be changed. It's about observing the care you are already receiving.

If you meet certain extra criteria, you might be asked to take part in additional assessments. This could involve some simple tests for frailty and memory, especially if you are over 65. Some patients might also be asked to have a special heart MRI scan to check their heart health, and blood samples might be collected for future research. These extra assessments would be discussed with you, and you would need to agree to them separately.

All participants will have their medical records reviewed to gather information about their diagnosis, treatments, and how they are doing. The total duration of your active involvement in the study, if you only participate in the main observation, would be for 12 months. Any additional tests like frailty assessments or an MRI might add a bit more time to your clinic visits on specific days.

Potential risks and benefits

Participating in this study will help doctors learn more about the best ways to treat severe leg circulation problems and potentially reduce the need for amputations. While there are no direct medical benefits to you personally from simply being observed, your information will contribute to a better understanding of the condition and could improve care for future patients. If you take part in extra assessments like special heart scans or blood tests, there are minor risks associated with the procedures themselves, which the study team will explain fully. For instance, an MRI involves being in a scanner, and some people find this uncomfortable. Blood tests involve a small needle stick. Remember, you can choose to withdraw from this study at any time without affecting your medical care.

Locations (1)

Glenfield Hospital Leicester
Leicester, United Kingdom· Recruiting

Common questions

What is 'severe limb ischaemia'?

It's a serious condition where your leg has very poor blood flow, causing pain or sores, and potentially threatening the limb.

Will my treatment change if I join this study?

No, your medical care and treatment will be decided by your doctors as usual. This study just observes what happens.

What is a 'biobank'?

A biobank is like a library where samples (like blood) are stored safely for future research to discover new ways to help patients.

How long will I be involved in the study?

The main part of the study involves following your progress for 12 months. Any extra tests would be during that time.

Can I leave the study if I change my mind?

Yes, you are free to withdraw from the study at any time, and it will not affect the medical care you receive.

How to find out more

Rob D Sayers, MD

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

Always speak to your GP or specialist before deciding to take part in a study.