Proof of Concept, Randomized, and Crossover Study, to Assess the Effectiveness of Two Types of Compression Garments in Lipedema

Recruiting now · Not applicable

Conditions studied: Lipedema

In brief

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.

Key facts

Study ID

NCT06964828

Run by

Isabel Forner-Cordero, MD, PhD

People needed

34

Starts

2024-05-08

Expected to finish

2026-07-01

Last updated by the study team

2025-05-14

Who can join

Age: 18 and older, up to 70. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Hospital Universitari i Politecnic La Fe — Valencia, Valencia, Spain (enrolling)

Full record on ClinicalTrials.gov

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