Not yet recruitingNAINTERVENTIONAL

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

This study is testing a new device called the Dynamic Decongestive System (DDS) for people with long-term leg swelling, known as lymphoedema. After an initial intensive treatment, individuals will either use the new DDS alongside compression stockings or continue with their usual compression treatments. The main goal is to see if the DDS, when used with compression garments, is as effective as current standard treatments in keeping leg swelling under control. It aims to make managing lymphoedema easier and more consistent at home. The study will follow participants for 12 weeks to see how their swelling responds to the different approaches.

At a glance

Status

Not yet recruiting

Phase

Sponsor

Jean-Paul Belgrado

Enrolment target

Start

01 Jul 2026

Estimated completion

30 Sep 2027

Lymphedema Lower Extremity

What is this study about?

Lymphedema is a long-term condition where fluid builds up, often in the legs, causing swelling. It can make daily activities harder and lead to problems like skin infections. While there's no cure, treatments can help manage the swelling and improve quality of life. The typical approach involves an initial intensive treatment phase to reduce swelling, followed by a lifelong 'maintenance' phase to keep the swelling down. This maintenance phase usually relies on special compression garments and other devices.

However, keeping lymphedema under control in the long run can be challenging. Current treatments, like special bandages or compression stockings, can sometimes be difficult to use consistently or might not always be enough to prevent swelling from returning. This can happen because these treatments can be time-consuming or might need frequent adjustments, making it hard for people to stick to them every day. When swelling isn't well controlled, it can lead to more discomfort and health issues.

This study is looking at a new device called the Dynamic Decongestive System (DDS). It's designed to make compression therapy easier and more consistent for people to use at home. The goal is to see if this new DDS, when used with regular compression stockings, works just as well as the current standard compression treatments in managing leg swelling during the important maintenance phase. The hope is that this new system could offer a more user-friendly way to keep lymphedema under control.

Key takeaways

Tests a new device (DDS) for long-term leg lymphedema management.
Compares DDS with existing compression treatments.
Focuses on maintaining reduced swelling after initial hospital care.
Participation involves 12 weeks with 3 check-up visits.
Aims to find a potentially easier and more consistent treatment option.
You can continue manual lymphatic drainage if needed.

Who may be eligible?

To join this study, you need to be an adult (18 years or older) with swelling in one of your lower limbs (leg or foot) due to lymphedema. This swelling should be at a certain stage (Stage II or III, as defined by medical experts) and not related to active cancer treatment at the moment. You must also have recently finished an intensive hospital treatment phase for your lymphedema, where your swelling was reduced by at least 20%. Your leg shape needs to be suitable for using the study device, and you should be able to use it comfortably. Also, you need to be part of a social security or similar health insurance plan.

However, you cannot take part if you have swelling only in your thigh with a normal calf and foot, or if you have a different condition called lipedema. If both your legs have lymphedema, or if your lymphedema is linked to active cancer or ongoing cancer treatment, you won't be able to join. Other reasons you might not be able to participate include having certain heart problems, severe diabetes-related nerve damage, ongoing skin infections or open wounds on your leg, recent blood clots, or other serious health issues that could make compression therapy unsafe for you. People with pacemakers or stents in the compression area are also excluded.

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 or older?
Do you have lymphedema in only one of your lower limbs (leg/foot)?
Have you recently completed an intensive hospital treatment for lymphedema where your swelling significantly reduced?
Do you have suitable health insurance?
Do you have any serious heart conditions, severe diabetes issues, or active skin infections on your leg?
Can you comfortably use a compression device on your leg?

Answer every question to see your result.

What does participation involve?

If you join this study, you'll be enrolled on the very last afternoon of your intensive lymphedema treatment stay in the hospital, just before you go home. You'll then be placed into one of two groups. Both groups will wear an elastic compression garment (like a stocking) during the day and as much as possible at night, based on your comfort and medical advice.

If you're in the "DDS group," you'll also use the new Dynamic Decongestive System (DDS) device for at least 2 hours at the end of each day. You'll use this device by itself, without the elastic compression garment. If you're in the "Control group," you'll use other standard compression devices, such as special bandages, air-filled pumps, or compression wraps, as recommended by your healthcare team and based on your preference.

Throughout the study, you'll be allowed to continue receiving manual lymphatic drainage if needed. You will have three assessment visits: the first one on the day you leave the hospital, the second around 6 weeks later, and the final one around 12 weeks after you leave the hospital. Each visit will check on your progress and how the treatment is working. The study’s total duration for each participant is 12 weeks.

Potential risks and benefits

By taking part in this study, you might benefit from closer monitoring of your lymphedema and could potentially experience a better long-term control of your swelling if the new device proves more effective or easier to use. However, there's always a possibility that the new treatment might not work as well for you, or you might find either treatment approach uncomfortable or inconvenient. While compression therapy is generally safe, there are rare risks such as skin irritation or, in very sensitive individuals, potential effects on blood flow, which is why a thorough check-up is done before you join. There are no known major risks associated with participating beyond those already present with current lymphedema treatments. You have the right to withdraw from the study at any time, for any reason, without it affecting your future medical 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 where fluid builds up, causing swelling, usually in an arm or leg, because the body's drainage system isn't working properly.

What is a 'Dynamic Decongestive System (DDS)'?

It's a new device designed to help manage swelling by applying compression to your affected limb, aiming to be easier and more consistent than some older methods.

How long will I be in the study?

You will be in the study for about 12 weeks, with visits occurring around 6 and 12 weeks after you leave the hospital.

Will I still get my usual lymphedema treatment?

Yes, both groups will use elastic compression garments, and manual lymphatic drainage is also allowed, just as in regular care.

Is this new device available to everyone?

No, this device is still being studied, so it's not yet widely available outside of clinical trials like this one.

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.