Active not recruitingNAINTERVENTIONAL

Duplex UltraSound afTer Endo Revascularisation - Feasibility Randomised Control Trial (DUSTER)

Every year, thousands in the UK suffer from painful feet or wounds due to blocked leg arteries, which can sometimes lead to amputation if not treated. Keyhole surgery can open these blockages, but often new ones form within two years. This study, called DUSTER, wants to find out if having regular ultrasound scans after keyhole surgery helps keep these arteries clear. We're looking for adults who've just had this surgery. Participants will be split into two groups: one receiving extra ultrasound checks before their usual follow-up appointments, and the other just having their standard appointments. We will then compare how the groups fare to see if the extra scans are beneficial.

At a glance

Status

Active not recruiting

Phase

Sponsor

Mid and South Essex NHS Foundation Trust

Enrolment target

Start

14 Mar 2025

Estimated completion

01 Dec 2026

Chronic Limb Threatening Ischaemia

What is this study about?

Imagine your leg arteries are like pipes carrying blood to your feet. Sometimes these pipes can get blocked, causing pain or sores that don't heal. This is a condition called Chronic Limb Threatening Ischaemia, and if left untreated, it can be very serious, sometimes even leading to needing an amputation. To fix this, doctors often use a type of keyhole surgery where they use balloons or tiny tubes (stents) to open up the blocked arteries and get the blood flowing again.

While this surgery helps many people, unfortunately, about half of them might develop new blockages in their leg arteries within two years. Regular ultrasound scans can often spot these new blockages early. This study, called DUSTER (Duplex UltraSound afTer Endo Revascularisation), aims to see if having these extra, regular ultrasound scans after keyhole surgery can help prevent future problems.

We want to understand if these scans can help doctors make decisions sooner, potentially leading to earlier treatment if needed, and ultimately improving outcomes for patients. This study is taking place in several NHS hospitals across the country to make sure we get a good understanding of how it would work for different people.

Key takeaways

The DUSTER study looks at extra ultrasound scans after leg artery keyhole surgery.
It aims to see if earlier detection of new blockages improves outcomes.
Participants will be randomly assigned to either standard care or standard care plus extra scans.
The study lasts 12 months and involves clinic visits and possibly ultrasound scans.
No new risks, only potential benefits from earlier detection of problems.
Your medical care will continue as usual, regardless of participation.

Who may be eligible?

You might be able to join this study if you are an adult, aged 18 or older, and have recently had keyhole surgery to open up blocked arteries in your leg due to ongoing pain or unhealed wounds. The surgery must have been successful, meaning the artery is largely clear and you haven't had a major amputation on that leg. You should also be willing and able to attend follow-up appointments and scans.

However, this study isn't for everyone. You wouldn't be able to join if you had a different type of leg surgery to clear blockages (like an open bypass), or if you aren't well enough or don't want any further treatments for your arteries. People with certain serious infections, severe foot deformities, or those who can't take blood-thinning medication are also not suitable. We also can't include you if you've had similar keyhole surgery on the same leg area in the past year, or if you're already in another study that might affect these results.

Quick self-check

Are you 18 years old or older?
Have you recently (within the last 3 weeks) had successful keyhole surgery for blocked leg arteries causing pain or wounds?
Can you attend regular clinic appointments for a year?
Are you able to agree to take part in the study?
Have you NOT had bypass surgery for your leg arteries?
Are you NOT currently in another research study that might affect this one?

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

What does participation involve?

If you join the DUSTER study, you'll be randomly placed into one of two groups. Neither you nor your doctor will get to choose which group you are in.

One group will have standard care, which means you'll attend check-up appointments with your specialist doctor at 1 month, 6 months, and 12 months after your keyhole surgery. The other group will have these same standard check-up appointments, but you'll also have an additional ultrasound scan of your leg arteries shortly before each of these appointments (at 1 month, 6 months, and 12 months).

Towards the end of the study, some participants who had the extra scans might be invited for an interview (in person, by phone, or online) to share their experiences. We'll be looking at how well people attended their appointments and scans, and how the scans influenced any decisions about further treatment. The overall duration of your participation in the main part of the study will be 12 months.

Potential risks and benefits

There are no significant new risks from taking part in this study, as ultrasound scans are a common and safe procedure that doesn't use radiation. The main benefit for participants in the group receiving extra scans is that any new blockages might be found earlier, potentially leading to earlier treatment. For both groups, you'll receive careful monitoring of your leg health. The results of this study will help us understand the best way to care for people after keyhole surgery, which could benefit many patients in the future. Remember, you can choose to leave the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Mid & South Essex NHS Foundation Trust
Basildon, United Kingdom

Common questions

What is keyhole surgery?

It's a procedure where doctors use small wires and tubes to reach and open up blocked blood vessels, often using balloons or stents, to improve blood flow.

What is an ultrasound scan?

An ultrasound uses sound waves to create pictures of the inside of your body, like your blood vessels. It's safe and doesn't use X-rays.

What does 'randomly allocated' mean?

It means you'll be put into one of the study groups by chance, like flipping a coin. Neither you nor your doctor will choose which group.

Will I know which group I'm in?

Yes, you will know whether you are in the group receiving standard care or the group receiving additional ultrasound scans.

What if new problems are found during the study?

If any issues are found during your appointments or scans, your medical team will discuss them with you and recommend suitable treatment, just as they would normally.