RecruitingOBSERVATIONAL

Automated ABPI in Peripheral Arterial Disease a Pilot Study

This is a small, initial study looking into two new automated devices designed to measure blood pressure in your ankles and arms (called an ABPI test). This test helps check for Peripheral Arterial Disease (PAD), where narrowed arteries reduce blood flow to the limbs. The main goal is to see how accurate these devices are at finding PAD in different groups of people, including those who might not have symptoms, those with suspected PAD, and those who have had surgery for PAD. The study also aims to understand how easy and comfortable these devices are to use for both patients and the nurses or doctors. By doing this, researchers hope to find better, simpler ways to diagnose and monitor PAD.

At a glance

Status

Recruiting

Sponsor

Hull University Teaching Hospitals NHS Trust

Enrolment target

400

Start

24 Jun 2026

Estimated completion

01 Sep 2028

Peripheral Arterial Disease (PAD)Ankle Brachial Index Diagnostic Accuracy Feasibility Studies

What is this study about?

This study, called a 'pilot study', is like a small-scale test run to see if something new works well before trying it on a larger scale. In this case, researchers are looking at two new automatic devices that can measure blood pressure in your ankles and arms. This measurement is called an ABPI (Ankle Brachial Pressure Index) and it's a common way to check for a condition called Peripheral Arterial Disease (PAD).

PAD happens when your arteries, especially those going to your legs, become narrowed or blocked, reducing blood flow. This can cause pain when walking or, in more serious cases, lead to ulcers or wounds that don't heal. Diagnosing PAD early is important to manage the condition and prevent it from getting worse.

The researchers want to see two main things: first, how accurate these new automatic machines are at finding PAD in different people compared to current methods. Second, they want to find out how easy and comfortable these devices are to use for patients and the healthcare professionals. The study will involve talking to patients and staff about their experiences. The aim is to find easier and more reliable ways to test for PAD in the future.

Key takeaways

This study evaluates new automatic machines for checking leg circulation (ABPI test).
It aims to see how accurate and user-friendly these devices are for diagnosing and monitoring PAD.
Participation involves a simple, non-invasive blood pressure check on your arms and ankles.
Your feedback on comfort and ease of use is important for future improvements.
This is a pilot study, meaning a small, initial test run.

Who may be eligible?

To join this study, you need to be an adult, aged 18 or over, who can speak English and understand what's involved. The study is looking for people from different groups.

Some participants will be people who haven't been diagnosed with PAD but are at higher risk, perhaps due to other health conditions. Other groups include those who have symptoms that suggest they might have PAD, such as leg pain when walking (known as 'intermittent claudication'), or more severe symptoms like non-healing wounds. Finally, people who have had bypass surgery in their leg arteries and are having regular check-ups are also invited to take part.

There are also some reasons why you wouldn't be able to join. For example, if you've had recent leg surgery (in the last month), have certain skin conditions like ulcers, casts or bandages that cover your ankle or arm, or if you can't lie flat for a period. People with severe swelling in their feet, an arm fistula (a special connection for dialysis), or problems with shaking or tremors would also not be able to participate.

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?
Can you understand English and the study information?
Can you lie flat comfortably for the test?
Have you *not* had leg surgery in the last 4 weeks?
Do you *not* have significant leg/foot swelling or wounds that can't be touched?
Are you *not* currently being treated for a blood clot in your leg?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would undergo a simple test where your blood pressure is measured in your arms and ankles using one or both of the new automatic devices. This is similar to a standard blood pressure check but includes your ankles as well. The test is usually done while you are lying down.

After the test, some participants will be asked to have a short chat (a 'semi-structured interview') with a researcher. This chat will be about your experience with the devices, asking what you found easy or difficult, and how comfortable it was. Healthcare staff involved in using the devices will also be interviewed to get their feedback.

There are no medications involved in this study. The total duration of your involvement would be limited to the time taken for the blood pressure measurements and, if applicable, the interview, likely taking less than an hour in total. There is no long-term follow-up required from you for this specific study.

Potential risks and benefits

Participating in this study might offer a small benefit by getting a detailed check of your blood pressure in your limbs, which could help identify or monitor PAD. There are very few risks involved; the devices are similar to standard blood pressure cuffs, so you might feel a brief squeezing sensation on your arm and ankle, which some people find a little uncomfortable, but this is usually well-tolerated. It's important to remember that you are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Hull University Teaching Hospitals NHS Trust
Verified postcode
Hull, United Kingdom· Recruiting

Common questions

What is Peripheral Arterial Disease (PAD)?

PAD is a condition where narrowed arteries reduce blood flow to your limbs, most commonly the legs. It can cause pain when walking or, in more severe cases, lead to foot ulcers.

What is an ABPI test?

ABPI stands for Ankle Brachial Pressure Index. It's a simple test that compares the blood pressure in your ankle to the blood pressure in your arm. A lower ankle pressure can suggest PAD.

Will I get results from this study?

While the study is to test the devices, any significant health findings relevant to your care would be communicated to your doctor, as with any routine medical test.

Do I have to do anything special before the test?

Generally, no. You'll just need to be able to lie comfortably for a short period. Any specific instructions would be given to you by the study staff.

What if I change my mind about taking part?

You are completely free to withdraw from the study at any point, without needing to give a reason, and it will not affect your medical care in any way.

How to find out more

Jon Prosser

jonathon.prosser@nhs.net 01482 674703 Official trial record

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