RecruitingNot ApplicableNCT06964828

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

Proof of Concept, Randomized, Controlled, and Crossover Study, to Assess the Effectiveness of Two Types of Compression Garments (Flat vs Circular Knitted) in the Maintenance Treatment of Patients With Lipedema

Sponsor

Isabel Forner-Cordero, MD, PhD

Enrollment

34 participants

Start Date

May 8, 2024

Study Type

INTERVENTIONAL

Conditions

Lipedema

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.

Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 70 Years

Inclusion Criteria6

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 Criteria10

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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