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Study on the Use of Indocyanine Green to Assess Lymphatic Vessel Porosity in Women with Lipedema

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying lipedema, a condition characterized by an abnormal buildup of fat in the legs and sometimes arms, leading to pain and easy bruising. The study aims to explore the use of a special imaging technique to better understand the condition. The treatment being tested involves a substance called indocyanine green, which is a type of fluorescent contrast agent. This agent is used in a very low concentration to help visualize the lymphatic vessels, which are part of the body's immune system and help in fluid balance.

The purpose of the study is to compare the porosity, or how easily fluid passes through, of the superficial lymphatic vessels in women with lipedema versus those in healthy individuals. This will help determine if the imaging technique, known as Near Infra-Red Fluorescence Imaging (NIRFI), can be a useful tool for diagnosing lipedema. The study involves injecting the indocyanine green just under the skin and then using the imaging technique to observe how the lymphatic vessels behave.

Participants in the study will undergo this imaging process, and researchers will observe the fluorescence in the area around the lymphatic vessels. They will also measure how quickly the contrast moves through the vessels and the pressure needed to block the flow in these vessels. The study is designed to provide insights into the differences in lymphatic vessel function between those with lipedema and those without, potentially leading to better diagnostic methods for this condition.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, you will be required to sign an informed consent form. This form confirms your understanding of the study and your agreement to participate.

    Eligibility criteria include being a woman aged 18-50 years, having a body mass index (BMI) between 18 and 30, and a waist-to-hip ratio of 0.7 or less. You should also have a pain level of 4 or higher on a visual scale and have been diagnosed with lipedema by a health professional.

  2. Step 2

    Medication administration

    You will receive an injection of a solution called Verdye 5 mg/ml, which contains the active substance indocyanine green. This is administered intradermally, meaning it is injected into the skin.

    The purpose of this injection is to help visualize the lymphatic vessels during the study.

  3. Step 3

    Observation and measurement

    The main objective of the study is to observe the fluorescence in the area around the superficial lymphatic vessels. This helps in assessing the porosity of these vessels.

    Secondary objectives include measuring the speed at which the injected solution moves between two points on the skin and determining the pressure at which the lymphatic vessels become blocked.

  4. Step 4

    Duration of participation

    The study is expected to continue until November 1, 2024. Your participation will involve attending scheduled appointments for observations and measurements as outlined by the study team.

Who can join the trial?

8 criteria

  • Must be a woman.
  • Age between 18 and 50 years old (not yet reached menopause).
  • Must sign an informed consent form, which means you agree to participate after understanding the study.
  • BMI (Body Mass Index) should be between 18 and 30. BMI is a measure of body fat based on height and weight.
  • Waist to hip ratio should be 0.7 or less. This is a measure of the proportion of your waist circumference to your hip circumference.
  • Experience easy bruising.
  • Have a pain level of 4 or higher on a scale called VAS (Visual Analogue Scale), which measures pain intensity.
  • Must have been diagnosed with lipedema syndrome by a health professional.

Who cannot join the trial?

3 criteria

  • Only women can participate in the study. Men are not eligible.
  • Participants must be within a specific age range. If you are outside this range, you cannot join the study.
  • If you belong to a vulnerable population, you are not eligible. This means groups that might need special protection or care.
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Investigated drugs

The clinical trial described does not mention any specific medications or therapies by name. The focus of the trial is on assessing the porosity of superficial lymphatic vessels in women with lipedema compared to healthy subjects, using ICG lymph-fluoroscopy as a diagnostic tool. Therefore, there are no medications or therapies to list from the provided information.

What is already known about the treatment

There is no specific medication mentioned in the provided data for the clinical trial.

Investigated diseases

Lipedema – Lipedema is a chronic condition characterized by an abnormal accumulation of fat, primarily in the lower body, such as the hips, thighs, and buttocks. This condition often leads to a disproportionate body shape, as the upper body remains unaffected. The progression of lipedema involves increased sensitivity and tenderness in the affected areas, often accompanied by easy bruising. Over time, the skin may become less elastic, and the affected areas can feel cooler to the touch. As the condition advances, mobility may be impacted due to the increased weight and discomfort. The condition is often confused with obesity, but it is distinct due to its specific pattern of fat distribution and associated symptoms.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-513529-21-00Estimated enrolment60 patientsSponsorUniversite Libre de Bruxelles

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