Not yet recruitingNAINTERVENTIONAL

Assessment of the Efficacy of the Dynamic Decongestive System in the Intensive Phase of Lower Limb Lymphedema

This study is looking at new ways to treat swelling in the legs, called lower limb lymphedema. Lymphedema is a long-term condition that causes swelling and can be difficult to manage. The study will compare a new type of compression device, which gently changes pressure, with the standard method of using multi-layered bandages. Both treatments will be worn for 24 hours a day during the first five days of intensive treatment. The main goal is to find out which method is better at reducing the amount of swelling in the leg. This could help make treatment easier and more effective for people with lymphedema in the future.

At a glance

Status

Not yet recruiting

Phase

Sponsor

Jean-Paul Belgrado

Enrolment target

110

Start

01 Jul 2026

Estimated completion

30 Dec 2027

Lymphedema Lower Extremity

What is this study about?

Lymphedema is a condition where fluid builds up, usually in the arms or legs, causing swelling. For many people, especially after cancer treatment, this swelling can be a real challenge, affecting daily life, how they feel about themselves, and their overall well-being. It's a lifelong condition that needs ongoing care, starting with an intensive period to reduce the swelling as much as possible, followed by continuous management to keep it under control. Reducing the swelling is important not only for comfort and movement but also to lower the risk of infections.

Currently, a common way to reduce severe swelling is using special bandages that are wrapped around the limb. These bandages work well, but they need to be applied by a trained professional, can be time-consuming to put on and take off, and often need to be re-tightened as the swelling goes down. Because of these challenges, researchers are always looking for new and better ways to help people manage their lymphedema, especially methods that are easier to use and just as effective, or even more so.

This study will compare the traditional bandaging method with a newer approach – a dynamic compression device. This device is designed to apply changing pressure to the limb, which might be an easier and more consistent way to reduce swelling. By comparing these two methods directly, we hope to learn if this new device could offer an improved treatment option for people with lower limb lymphedema, potentially making the intensive phase of treatment more efficient and less burdensome.

Key takeaways

This study compares a new device to traditional bandages for leg swelling (lymphedema).
It focuses on how much swelling is reduced during the first 5 days of intense treatment.
Lymphedema is a long-term condition often needing continuous care.
The new device might offer an easier way to manage leg swelling.
Participation involves 5 days of intensive treatment with either bandages or the device.
The goal is to find better ways to help people with lymphedema.

Who may be eligible?

This study is looking for adults aged 18 or over, both men and women, who have swelling in only one of their lower legs due to lymphedema. This swelling should be at a moderate or severe stage (stage II or III) and noticeably larger than their healthy leg (at least 10% more volume). You would need to be well enough to be in hospital for intensive treatment and be able to use the compression device.

There are certain reasons why you might not be able to join. For example, if you have swelling in both legs, or if your lymphedema is only in your thigh with a normal calf and foot. If you have lymphedema caused by active cancer that needs chemotherapy, or if your cancer has come back, you wouldn't be able to participate. Also, certain serious health conditions, especially those affecting your heart, lungs, blood vessels in your legs, kidneys, or if you have open sores or skin infections, would prevent you from joining. This also includes conditions like advanced diabetes affecting your blood vessels, or if you have a pacemaker.

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?
Do you have lymphedema in only one of your lower legs?
Is your swollen leg noticeably larger than your healthy leg?
Are you able to go to the hospital for a short intensive treatment period?
Do you not have any major heart, lung, or blood vessel problems that would make compression therapy unsafe?
Do you not have active skin infections or open wounds on your leg?

Answer every question to see your result.

What does participation involve?

If you join this study, you'll receive intensive treatment for your lymphedema over five days. You'll be assigned to one of two groups: either you'll wear the traditional multi-layer compression bandages, or you'll use the new dynamic compression device. Whichever group you're in, you’ll wear the compression for 24 hours a day during these five days. During this time, you'll also follow the standard lymphedema treatment protocol at the hospital, which might include things like exercise and skin care. The research team will measure your leg swelling before and after the five-day period to see how effective the treatment was. Your participation in this specific part of the study will last for approximately five days.

Potential risks and benefits

Taking part in this study could potentially offer you an effective intensive treatment for your lymphedema, and you might experience a significant reduction in swelling. The new dynamic compression device is being tested because it might offer a more comfortable and easier-to-manage alternative to traditional bandaging, which could be a benefit if you are in that group. As with any medical treatment, there's always a small chance of discomfort or side effects from the compression therapy, such as skin irritation, though these would be carefully monitored. You'll be informed of any known risks specific to the treatment you receive. Remember, your participation is completely voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your usual care.

Locations (3)

CHU Montpellier - Saint Eloi
Verified postcode
Montpellier, France
CHU Toulouse - Rangueil
Verified postcode
Toulouse, France
Lympho-Opt Fachklinik fur Lymphologie
Verified postcode
Pommelsbrunn, Germany

Common questions

What is lymphedema?

Lymphedema is a long-term condition that causes swelling, often in the arms or legs, due to a build-up of fluid in the body's tissues.

What is a 'dynamic compression device'?

It's a newer type of medical device that applies gentle, changing pressure to your limb to help reduce swelling, potentially making treatment easier.

Will I know which treatment I'm getting?

Yes, you will know if you are receiving the traditional bandages or the dynamic compression device, as these are visible treatments.

How long will I wear the compression?

Both groups in the study will wear their assigned compression device or bandages for 24 hours a day during the five days of intensive treatment.

What is the main goal of the study?

The main goal is to compare how well the new dynamic compression device and traditional bandages reduce swelling in the legs during the first five days of intensive lymphedema treatment.

How to find out more

Prof. Jean-Paul Belgrado, PhD

jp.belgrado@gmail.com +33 6 38 39 79 56 Official trial record

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