CompletedPhase IIObservational

A pilot study to observe the use of a portable Pneumatic compression pump as part of self-management in swollen legs

This study is testing a new, portable pump called the Haddenham Lymphflow Go. It's designed to help reduce swelling in legs, especially for people with conditions like lymphoedema or chronic venous insufficiency. Researchers want to find out if this device is safe and effective when used by people at home as part of their self-care routine. Participants will have an initial visit, where they'll learn about the device and use it once. They'll then take the device home to use daily for two weeks, before returning for a final check-up. The study hopes to improve or maintain participants' leg swelling, but there's a small risk of discomfort.

At a glance

Status

Completed

Phase

Phase II

Sponsor

Louis Wakelin Haddenham Healthcare Ltd

Enrolment target

Start

02 Jun 2025

Estimated completion

02 Sep 2025

Lymphoedema and chronic venous insufficiency

What is this study about?

This study is about a small, portable pump called the Haddenham Lymphflow Go. It's designed to help reduce swelling in the legs, which can happen with conditions like lymphoedema (where fluid builds up) or chronic venous insufficiency (when leg veins don't work as well as they should). We already know this device is safe for healthy adults, and now we want to test it on people who actually have swollen legs to see if it's both safe and helpful in real-life use.

The main aim is to see how well people can manage their leg swelling themselves using this device at home. We want to understand if it can make a real difference in reducing swelling and improving their daily lives. By doing this study, we hope to find new and easier ways for people to look after their swollen legs.

This research is important because it could lead to better ways for people in the UK to manage their conditions at home, giving them more control over their health. If the device works well, it could become a useful tool for many people living with swollen legs.

Key takeaways

This study is testing a portable pump for swollen legs.
It aims to see if the device is safe and helps with conditions like lymphoedema.
Participation involves two clinic visits and using the device at home for two weeks.
Potential benefits include reduced swelling; main risk is discomfort from the device.
The study is running in Malvern from November 2024 to September 2025.
It's important to meet specific health and mobility requirements to join.

Who may be eligible?

You might be able to join this study if you have been diagnosed with certain conditions that cause leg swelling, such as lymphoedema (primary or secondary), swelling after an injury or surgery, problems with your leg veins (venous insufficiency), or associated skin issues like ulcers. You also need to be able to understand the study information and follow instructions for using the device.

It's important that you can move around well enough to lift your legs when sitting and get into position on a treatment couch. Your body mass index (BMI) — a measure of your weight compared to your height — needs to be less than 32. You must also be aged 18 or over.

Unfortunately, you can't join if you have serious heart or vein conditions, an active skin infection in your leg, are pregnant, or if your doctor advises that increasing fluid movement in your legs would be unsafe for you.

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.

Do you have a diagnosis of lymphoedema, venous insufficiency, or other described leg swelling?
Are you able to understand instructions and give your consent?
Can you lift your legs easily and position yourself on a treatment couch?
Is your BMI (Body Mass Index) less than 32?
Are you aged 18 or older?
Do you *not* have severe heart conditions, active skin infections, or pregnancy?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll first visit a clinic in Malvern. During this visit, you'll get detailed information about the study, sign a consent form, and have your legs measured and photographed. You'll also fill out a questionnaire about your quality of life and try the device for one treatment session.

After this, you'll take the device home and use it every day for two weeks as instructed. After these two weeks, you'll have a final appointment back at the clinic to have your legs measured and photographed again. You'll also return the device and fill out another quality of life questionnaire. The total time you'll be involved in the study, from your first visit to your last, will be about two and a half weeks.

Potential risks and benefits

Taking part in this study might offer potential benefits, such as seeing an improvement in your leg swelling or helping to keep your condition stable. However, like with any new treatment, there are some potential risks. You might feel some discomfort or pain when using the device, or the device itself might not work correctly. We will provide full training to show you how to use it safely, and you'll get clear instructions to help reduce these risks. If you experience any discomfort, you should stop using the device immediately and contact the study team. You are free to withdraw from the study at any time without giving a reason, and this won't affect your future medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

The Lighter Touch
City only
Great Malvern, United Kingdom

Common questions

What is lymphoedema?

Lymphoedema is a long-term condition that causes swelling, usually in the arms or legs, because the lymphatic system isn't working properly to drain fluid.

What is the Haddenham Lymphflow Go device?

It's a small, portable pump designed to help reduce swelling in legs by gently squeezing them to move fluid, similar to how compression bandages work.

How long will I need to use the device?

If you join the study, you'll use the device daily at home for two weeks.

Where is the study taking place?

The study is being run from a clinic called 'The Lighter Touch' in Malvern, UK.

Will I have to pay to be in the study?

No, you will not have to pay to participate in this research study.

How to find out more

Natalie Dawn Phillips

natalie@lymphatic.co.uk +44 7359151323 Official trial record

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