RecruitingOBSERVATIONAL

Acceleration Time Assessment for Prediction of Critical Limb Ischemia

This study aims to find a quicker and more reliable way to diagnose a serious circulation problem in the legs called Critical Limb Ischaemia (CLI). CLI is the most severe stage of artery disease and needs urgent treatment. Currently, diagnosing CLI can be complicated and varies between different medical groups. This research will use a special type of ultrasound scan, called a Doppler ultrasound, to measure blood flow in the legs. The goal is to see if measuring how quickly blood flow increases in the foot arteries can help doctors identify CLI earlier. Finding an accessible and accurate diagnostic tool means patients can get referred for specialist care as soon as possible, improving their chances of a better outcome.

At a glance

Status

Recruiting

Sponsor

Centre Hospitalier le Mans

Enrolment target

431

Start

01 Jul 2024

Estimated completion

01 Sep 2026

Critical Limb Ischemia

What is this study about?

This study is all about finding a better and faster way to diagnose a very serious condition called Critical Limb Ischaemia, or CLI. CLI is when the blood flow to your legs is severely reduced, often causing pain even when resting, or wounds that don't heal. It's the most advanced stage of artery disease and needs urgent attention.

Currently, diagnosing CLI can be a bit tricky, and different doctors and hospitals might use slightly different methods. Often, it involves looking at symptoms like ongoing pain or non-healing wounds, combined with blood pressure measurements in your ankles or toes. This study wants to see if a specific measurement from an artery ultrasound scan – how quickly the blood flow increases – can give us a clearer and earlier sign of CLI.

The main goal of this research is to develop an easy-to-use and reliable way to check for CLI. If we can identify patients with CLI sooner, they can be sent to specialist centres more quickly for the treatment they need. This could make a big difference in how well patients recover and help reduce the health costs associated with this condition.

Key takeaways

A study to find a better way to diagnose severe circulation problems in legs.
Uses a special type of ultrasound scan to measure blood flow.
Aims for earlier diagnosis of Critical Limb Ischaemia (CLI).
May help patients get specialist care sooner in the future.
Participation involves routine diagnostic tests, not new treatments.

Who may be eligible?

To join this study, you need to be at least 18 years old. You'd be included if your doctor has referred you for an ultrasound scan of your leg arteries because they suspect you might have, or already have, some kind of artery problem in your legs.

Specifically, you'd qualify if previous tests show that the blood pressure in your ankle is 0.90 or less compared to your arm, or the blood pressure in your toe is 0.70 or less. These numbers tell us if the blood flow to your lower leg and foot is reduced.

You wouldn't be able to join if you're in a very unstable health condition that means you can't wait for your treatment, or if you already have surgery planned for your leg artery problem. Also, if you have a very short time left to live (less than 24 hours), or if you've had a foot amputation that would stop us from doing the necessary measurements, you wouldn't be eligible. And of course, you must be willing to take part.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Have you been referred for an ultrasound scan of your leg arteries?
Is your ankle blood pressure index 0.90 or less, or toe blood pressure index 0.70 or less?
Are you able to delay any urgent treatment if needed to have the scan?
Have you *not* had a leg amputation that would stop toe pressure measurement?

Answer every question to see your result.

What does participation involve?

This study involves having an arterial ultrasound scan of your leg. During this scan, the researchers will also measure the blood pressure in your toe, which is a standard part of assessing blood flow. There's no specific medication involved in this study, and no follow-up visits are described beyond the initial assessment. The total duration for your participation will likely be limited to the time it takes to complete these scans and measurements.

Potential risks and benefits

Taking part in this study may offer the benefit of helping doctors find a faster and more accurate way to diagnose Critical Limb Ischaemia, which could lead to earlier treatment for future patients. For you directly, you will receive the standard arterial ultrasound and toe pressure measurements, which are part of routine care when circulation problems are suspected. The risks associated with an ultrasound scan are very low, as it uses sound waves and not radiation. Measuring toe pressure is also a routine, low-risk procedure. You have the right to withdraw from the study at any time without affecting your medical care.

Locations (3)

Centre Hospitalier de CHOLET
Verified postcode
Cholet, France· Recruiting
Centre Hospitalier du Mans
Verified postcode
Le Mans, France· Not yet recruiting
CHU Poitiers
Verified postcode
Poitiers, France· Recruiting

Common questions

What is Critical Limb Ischaemia (CLI)?

CLI is a very serious condition where the blood flow to your legs and feet is severely reduced, causing pain even when resting, and sometimes non-healing wounds.

What is an arterial ultrasound scan?

It's a painless test that uses sound waves to create pictures of the blood vessels in your legs and see how blood is flowing through them.

Will I get any special treatment in this study?

No, this study is about improving diagnosis, not providing new treatments. You'll receive standard care for your condition.

Is the study suitable for children?

No, this study is for adults aged 18 and over.

How long will my participation take?

Your participation will be limited to the time needed for the ultrasound scan and blood pressure measurements during your scheduled appointment.

How to find out more

Christelle JADEAU

cjadeau@ch-lemans.fr +33244710781 Official trial record

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