RecruitingInterventional

Using exercise as a prevention tool for venous leg ulcers

This study, called FISCU-III, is testing if a special exercise and lifestyle programme can prevent venous leg ulcers (painful leg wounds) from returning after they've healed. These ulcers affect many people in the UK, causing pain and costing the NHS a lot. While current treatments help ulcers heal, many come back. The researchers have developed a 12-week exercise programme that earlier studies found safe and enjoyable. This new study will see if following this programme for 12 months, alongside usual compression therapy, makes a difference compared to just receiving compression therapy. It involves check-ups over a year to see how people's health, fitness, and ulcer history are affected.

At a glance

Status

Recruiting

Sponsor

Sheffield Health and Social Care NHS Foundation Trust

Enrolment target

Start

01 Aug 2025

Estimated completion

01 Aug 2026

Venous leg ulcers

What is this study about?

Venous leg ulcers are sore, open wounds on the legs that happen when blood doesn’t flow properly through the veins. They can be very painful, make it hard to move around, and stop people from doing everyday things. Many people in the UK are affected by these ulcers each year, and treating them is a big cost for the NHS.

While treatments like compression bandages and stockings help these ulcers get better, unfortunately, they often come back. Because of this, researchers are looking for better ways to prevent them from returning. They have created an exercise and lifestyle programme that was shown in earlier trials to be safe and enjoyable.

This new study, called FISCU-III, wants to find out if this 12-month exercise programme can help stop leg ulcers from returning after they have healed. It will compare people who do the exercise programme along with their usual care (compression therapy) against those who only receive usual care. The goal is to see if regular physical activity can make a real difference in preventing these ulcers and improving people's overall health.

Key takeaways

This study explores if exercise can prevent leg ulcers from returning.
It involves a 12-month exercise programme alongside usual care.
You must live in Sheffield and have a recently healed venous leg ulcer to participate.
The study compares an exercise group with a group receiving only usual care.
Participants will have regular health checks over one year.
The programme is designed to be safe and enjoyable.

Who may be eligible?

To be considered for this study, you need to be an adult between 18 and 80 years old and currently live in Sheffield. You must have recently, for example, within the last three months, had a venous leg ulcer that has now fully healed. You also need to be able to comfortably wear lower-leg compression, such as bandages or stockings, as part of your care.

However, there are some reasons why you might not be able to join. For example, if your doctor thinks you wouldn't be able to understand or complete the study tasks, or if you are pregnant, you wouldn't be able to take part. Also, if you need to have major surgery planned within the next three months, you wouldn't be eligible. The study is open to both men and women.

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 between 18 and 80 years old?
Do you currently live in Sheffield?
Have you had a venous leg ulcer that healed within the last three months?
Can you comfortably wear compression bandages or stockings on your leg?
Are you able to understand and take part in study assessments?
Are you not pregnant and don't have major surgery planned soon?

Answer every question to see your result.

What does participation involve?

If you join this study, you will be splitting into one of two groups by chance – like drawing names from a hat. One group will follow a 12-month exercise and lifestyle programme, which you manage yourself, but with support from trained staff over the phone and sometimes in person. You'll also receive your usual compression therapy. The other group will only receive their usual compression therapy.

Everyone in the study will have some health checks at the very beginning. Then, you'll have follow-up checks after 3 months, 6 months, and 12 months. These checks will look at things like your fitness, how flexible you are, your quality of life, if you've had any new ulcers, and if you've had any falls. You'll also be asked about your experience in the study. The total study time for each person is 12 months.

Potential risks and benefits

Taking part in this study could offer some real benefits. It may help prevent your leg ulcers from coming back and could also improve your general health and wellbeing. Previous studies showed that this exercise programme is safe and that people found it enjoyable. As with any physical activity, there's always a small chance of feeling a bit uncomfortable or having a minor injury, but you'll have support throughout the programme. Remember, you can choose to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Sheffield Hallam University
Approximate
Sheffield, United Kingdom

Common questions

What is a venous leg ulcer?

It's a painful sore on your leg caused by poor blood flow in your veins, often making it hard to move around.

What is the main goal of this study?

The study wants to see if regular exercise can help stop these painful leg ulcers from coming back once they've healed.

How long will I be involved in the study?

If you take part, your involvement will last for 12 months, with check-ups at regular intervals.

Do I have to move to Sheffield to join?

No, you just need to be living in Sheffield at the time of the study to be eligible.

Who is paying for this research?

The study is funded by the National Institute for Health and Care Research (NIHR) in the UK.

How to find out more

Markos Klonizakis

heartresearchuk@shu.ac.uk +44 1142256000 Official trial record

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