Proof of Concept, Randomized, and Crossover Study, to Assess the Effectiveness of Two Types of Co… (NCT06964828) | Clinical Trial Compass
RecruitingNot Applicable
Proof of Concept, Randomized, and Crossover Study, to Assess the Effectiveness of Two Types of Compression Garments in Lipedema
Spain34 participantsStarted 2024-05-08
Plain-language summary
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.
Who can participate
Age range
18 Years – 70 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.