Active not recruitingNAINTERVENTIONAL

Evaluation Between Surgical Therapy of Lipedema Compared to Complex Physical Decongestive Therapy (CDT) Alone

This research study aims to find out if liposuction surgery is a better treatment for leg pain caused by lipoedema (stages 1, 2, or 3) compared to a non-surgical treatment called Complex Physical Decongestive Therapy (CDT). CDT involves special massage, skin care, exercise, and compression garments to help manage swelling and discomfort. All participants will first receive CDT for up to seven months. After this, they will be randomly assigned to either continue with CDT or have liposuction surgery. The study focuses on women aged 18 and over who have significant leg pain from lipoedema and whose condition hasn't improved enough with conservative treatments. The main goal is to see how much leg pain changes 12 months after the final surgery, with further follow-up for two years.

At a glance

Status

Active not recruiting

Phase

Sponsor

Hautklinik Darmstadt

Enrolment target

450

Start

15 Jan 2021

Estimated completion

01 Sep 2026

Lipedema

What is this study about?

This study is looking into the best way to treat lipoedema in women. Lipoedema is a condition where fat builds up unusually, most often in the legs, and it can cause pain and discomfort. The researchers want to compare two main approaches: liposuction surgery, which removes fat, and Complex Physical Decongestive Therapy (CDT). CDT is a non-surgical treatment that involves special massage, skin care, exercise, and compression stockings or bandages to help manage the symptoms.

All women taking part will first have CDT for up to seven months. This is to help get their legs ready and to see how much the CDT helps. After this initial period, they will be randomly put into one of two groups. One group will continue with CDT as needed, and the other group will have liposuction surgery. The doctors will monitor their leg pain very carefully over time to see which treatment works better.

The main aim is to understand if liposuction can significantly reduce leg pain for women with lipoedema compared to just using CDT. This information will be really helpful for doctors and patients in the future to make informed decisions about treatment options for lipoedema.

Key takeaways

This study compares liposuction to a non-surgical therapy (CDT) for lipoedema leg pain.
It's for women aged 18+ with lipoedema in their legs and noticeable pain.
All participants start with up to 7 months of CDT.
You'll be randomly assigned to either surgery or ongoing CDT.
The main aim is to see if liposuction reduces leg pain more effectively.
Your progress will be monitored for several years.

Who may be eligible?

This study is looking for women who are 18 years old or older and have been diagnosed with lipoedema in their legs (stages 1, 2, or 3). You should be experiencing noticeable leg pain that averages 4 or more on a scale, and conservative treatments (like certain exercises or compression) haven't helped enough. You must also be generally well enough to have surgery, if you are placed in that group, and be willing to continue with conservative measures, like wearing compression, as part of the study.

Some reasons you might not be able to join include if you have lipoedema in your arms as well, if you've had liposuction before, or if you have certain health conditions like heart problems, uncontrolled diabetes, or severe infections. Also, if you weigh more than 120 kg, are pregnant, breastfeeding, or participating in another clinical study, you won't be able to take part. The study is specifically for those with true lipoedema, not other similar conditions or those seeking purely cosmetic improvements.

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 a woman aged 18 or older?
Have you been diagnosed with lipoedema in your legs (stages 1, 2, or 3)?
Do you experience leg pain that is moderate to severe?
Have other conservative treatments (like compression) not helped enough?
Are you generally well enough for surgery and able to commit to the study protocol?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll first have a 'run-in' period of up to seven months where you'll receive Complex Physical Decongestive Therapy (CDT). This therapy helps reduce swelling and maintain results through methods like special massage and compression. After this, if you still meet all the study requirements, you'll be randomly assigned to one of two groups. Two-thirds of participants will be assigned to the liposuction group, and one-third will continue with CDT.

If you're in the liposuction group, you might have up to four surgeries, with about 5 to 7 weeks between each one. You'll also continue with CDT if your doctors think it's necessary to help maintain the results of your surgery. Everyone in the study will have their leg pain checked regularly. After your final liposuction surgery (if you're in that group), your pain will be assessed 12 months later. The study will then continue to follow up with you for another 24 months to see how your condition progresses over time.

Potential risks and benefits

Taking part in a study like this can have potential benefits, such as receiving close medical attention for your lipoedema from experts. If you're in the liposuction group, you might experience a significant reduction in your leg pain. However, there are also potential risks with any medical procedure or treatment. Liposuction carries risks like pain, bruising, infection, and needing recovery time. Even with non-surgical treatments, there might be discomfort or the possibility that your condition doesn't improve as much as hoped. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (12)

Praxis für Dermatologie, Dermatochirurgie und Phlebologie
Verified postcode
Freiburg im Breisgau, Germany
Venenzentrum Freiburg
Verified postcode
Freiburg im Breisgau, Germany
Universitätsklinikum Regensburg
Verified postcode
Regensburg, Germany
Klinikum Ernst von Bergmann
Verified postcode
Potsdam, Germany
Hautmedizin Bad Soden
Verified postcode
Bad Soden am Taunus, Germany
Hautklinik Darmstadt
Verified postcode
Darmstadt, Germany
Hautarztpraxis Mühltal
City only
Mühltal, Germany
Evangelisches Krankenhaus Oldenburg Klinik für Plastische, Ästhetische, Rekonstruktive und Handchirurgie
Verified postcode
Oldenburg, Germany
Johanniter GmbH Waldkrankenhaus Bonn
Verified postcode
Bonn, Germany
Klinik und Praxisklinik für Plastische Chirurgie
Verified postcode
Cologne, Germany
MVZ Praxis
Verified postcode
Cologne, Germany
MVZ Praxis Dr. Cornely Düsseldorf MVZ Corius Nordrhein GmbH
Verified postcode
Düsseldorf, Germany

Common questions

What is lipoedema?

Lipoedema is a long-term condition mainly affecting women, where a specific type of fat builds up, typically in the legs and sometimes the arms. It can cause discomfort, pain, and bruising.

What is 'Complex Physical Decongestive Therapy'?

CDT is a non-surgical treatment that combines several approaches: special massage techniques, skin care, exercise, and compression (like special stockings or bandages) to help manage swelling and improve symptoms.

Will I definitely get liposuction if I join?

Not necessarily. After an initial period of CDT, you'll be randomly assigned to either receive liposuction or continue with CDT. There's a 2 in 3 chance you'd get liposuction.

How long will I be involved in the study?

The initial part with CDT can last up to seven months. After that, if you have liposuction, there might be several surgeries. Your leg pain will be assessed 12 months after the last surgery, and you'll be followed for a further 24 months.

Why do I need to have pain for this study?

This study is specifically looking at whether treatments can improve leg pain, so they are looking for participants who are currently experiencing a certain level of pain from their lipoedema.