Ongoing, recruitingTherapeutic use (Phase IV)Interventional

Basic Toolbox for Lipedema Syndrome Assessment ("BATOLISA")

The BATOLISA study aims to understand more about Lipedema, a condition where fat builds up abnormally, usually in the legs. Researchers are using a special dye, VERDYE, which is injected to help them see exactly how fluid moves around the small lymphatic vessels just under your skin. The main goal is to observe the glow (fluorescence) of this dye in the tissue surrounding these vessels. They will also measure how quickly the dye moves along these vessels and the pressure inside them. This is a Phase IV study, meaning the treatment (VERDYE) is already approved for other uses, and this study is looking at an additional way to use it to learn more about Lipedema.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic use (Phase IV)

Sponsor

Universite Libre de Bruxelles

Enrolment target

Start

09 Aug 2024

Lipedema Lipoedema

What is this study about?

This study, called "BATOLISA", is focused on understanding Lipedema, a condition that causes an abnormal build-up of fat, usually in the legs, arms, or buttocks. It's often misunderstood and can be difficult to diagnose properly.

The main aim of this research is to get a clearer picture of what's happening just beneath the skin in people with Lipedema. To do this, doctors will use a special dye called VERDYE. When this dye is injected, it glows under a specific light, allowing them to see how fluid behaves around the very small vessels (called lymphatic vessels) that are responsible for draining fluid from your tissues. By watching how this dye moves and where it goes, they hope to learn more about how Lipedema affects these important fluid-draining systems.

This is a 'Phase IV' study. This means that VERDYE, the dye used, is already approved and used by doctors for other medical reasons. In this study, doctors are investigating a new way to use it – as a tool to better understand Lipedema. The information gathered from this study could help improve how Lipedema is diagnosed and potentially lead to better treatments in the future.

Key takeaways

This study aims to understand Lipedema better.
It uses a special dye (VERDYE) to observe fluid movement under the skin.
It's open to women aged 18 and over with a Lipedema diagnosis.
The study could help improve future diagnosis and treatments.
VERDYE is an approved dye used in new ways for this research.
It's not a treatment, but an observation study.

Who may be eligible?

This study is specifically looking for women who are 18 years old or older. There is no upper age limit for taking part.

To be eligible, you must have been diagnosed with Lipedema. The research team will need to confirm this diagnosis before you can join.

If you are a woman aged 18 or over and have Lipedema, you might be able to take part in this study.

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?
Are you 18 years old or older?
Do you have a diagnosis of Lipedema?
Are you willing to have an injection of a special dye?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, the main part of it will involve receiving an injection of a special dye called VERDYE. This dye helps doctors see what's happening with your small fluid-draining vessels (lymphatics) just under your skin. They will use special equipment to observe how the dye moves and lights up the tissues. They will also measure how fast the dye travels and the pressure within these vessels. You won't need to take any medication regularly throughout the study. The number of visits and the total duration of the study are not specified here, but the researchers will explain all the details, including follow-up appointments, before you agree to participate.

Potential risks and benefits

Taking part in research always has a balance of potential benefits and risks. A potential benefit of this study is that it will help doctors understand more about Lipedema, which could lead to better ways to diagnose and treat the condition for others in the future. For you, there's no direct treatment benefit, but you might gain a deeper understanding of your own condition. Potential risks could include discomfort or a reaction at the injection site from the VERDYE dye. Allergic reactions to dyes are possible, although usually rare. The research team will explain all known risks. Remember, you have the full right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

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

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Unverified
Belgium

Common questions

What is Lipedema?

Lipedema is a medical condition, mostly affecting women, where abnormal fat builds up, typically in the legs and arms. It's often painful and doesn't go away with diet or exercise.

What is VERDYE?

VERDYE is a special dye that glows under a certain light. Doctors already use it for other medical purposes, and in this study, it helps them see how fluid moves under the skin.

Will this study cure my Lipedema?

No, this study is not designed to treat or cure Lipedema. Its main goal is to understand the condition better, which could help future research into treatments.

Is the VERDYE injection safe?

VERDYE is already an approved medical dye. As with any injection, there can be minor risks like discomfort or bruising. The study team will explain all known potential side effects.

How long will I need to be involved?

The information provided doesn't specify the exact duration, but the research team will explain the number of visits and the total time commitment involved before you agree to participate.