Status:
RECRUITING
Proof of Concept, Randomized, and Crossover Study, to Assess the Effectiveness of Two Types of Compression Garments in Lipedema
Lead Sponsor:
Isabel Forner-Cordero, MD, PhD
Collaborating Sponsors:
Hospital Provincial de Castellon
Hospital Arnau de Vilanova
Conditions:
Lipedema
Eligibility:
FEMALE
18-70 years
Phase:
NA
Brief 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 ...
Detailed Description
Lipedema, described by Allen and Hines in 1940, is a syndrome characterized by painful edema in the lower limbs associated with a frequent occurrence of bruises. It mainly affects women and is usually...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 8 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2026
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT06964828
Start Date
May 8 2024
End Date
July 1 2026
Last Update
May 14 2025
Active Locations (1)
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1
Hospital Universitari i Politecnic La Fe
Valencia, Valencia, Spain, 46026