Proof of Concept, Randomized, and Crossover Study, to Assess the Effectiveness of Two Types of Compression Garments in Lipedema
Recruiting
N/AInterventional Study
Lipedema
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
18 – 70
Sex
Female
Study type
Interventional
Purpose
Treatment
Participants needed
34 (estimated)
Sponsor
Isabel Forner-Cordero, MD, PhD · Other
Who this trial is looking for
This trial is looking for people with lipedema to see how well two types of compression garments work for managing their condition. Participants will wear either circular or flat-knit pantyhose daily for 6 months and then switch to the other type for another 6 months.
Are You a Good Fit for This Trial?
Must not be takingCorticosteroids
You may be able to join if
I have been diagnosed with lipedema.
I have lipedema type III stages 1 or 2.
I don't have pitting in my legs.
I have been using a class II circular-knitted compression garment for at least 6 months.
I wear my compression garments each day, except when bathing or swimming.
I agree to participate in the study by signing a consent form.
You may not be able to join if
I have lipedema with fatty lobulations.
My Body Mass Index (BMI) is 30 or higher.
My Waist-to-Height Ratio is greater than 0.53.
I am pregnant.
I have kidney, liver, or heart problems.
I have had blood clots in my legs.
I have an infection in my legs.
I currently have cancer.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
The goal of this prospective randomized crossover experimental study is to assess the effectiveness and tolerance of circular and flat fabric garments in stabilizing lower-limb volume in lipedema. It will assess the effectiveness of the garments and determine any differences between both types of hosiery currently used in routine clinical practice. Participants will be prescribed either circular o…
The goal of this prospective randomized crossover experimental study is to assess the effectiveness and tolerance of circular and flat fabric garments in stabilizing lower-limb volume in lipedema. It will assess the effectiveness of the garments and determine any differences between both types of hosiery currently used in routine clinical practice. Participants will be prescribed either circular or flat-knitted pantyhose and wear them daily for 6 months. After 6 months, they will change the type of garment.
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Eligibility Criteria
Inclusion Criteria:
* Clinical diagnosis of lipedema: increased lowe-limb volume, disproportion between upper and lower body, and pain.
* Lipedema type III stages 1 or 2.
* Negative pitting sign.
* In maintenance treatment phase with a class II circular-knitted compression garment for at least 6 mo…
Inclusion Criteria:
* Clinical diagnosis of lipedema: increased lowe-limb volume, disproportion between upper and lower body, and pain.
* Lipedema type III stages 1 or 2.
* Negative pitting sign.
* In maintenance treatment phase with a class II circular-knitted compression garment for at least 6 months.
* Adequate compliance with compression garments (worn during the day, except during personal hygiene and water-related activities).
* Written informed consent to participate.
Exclusion Criteria:
* Lipedema with fatty lobulations.
* Body Mass Index (BMI) ≥ 30 kg/m2.
* Waist-to-Height Ratio \> 0.53.
* Pregnancy.
* Renal, hepatic, or cardiac insufficiency.
* Thrombosis in the lower extremities.
* Infection in the lower extremities.
* Active oncological process.
* Current treatment with corticosteroids and other medications that promote fluid retention.
* Inability to read the Patient Information Form (HIP) and/or provide consent to participate in the study.
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