Assessing the effectiveness of two types of compression garments for 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
NA · Instituto de Investigacion Sanitaria La Fe · NCT06964828
This study is testing whether circular or flat compression garments work better for helping people with lipedema manage swelling in their legs.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 34 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | Female |
| Sponsor | Instituto de Investigacion Sanitaria La Fe (other) |
| Locations | 1 site (Valencia, Valencia) |
| Trial ID | NCT06964828 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness and tolerance of circular versus flat fabric compression garments in stabilizing lower-limb volume in patients with lipedema. Participants will wear one type of garment daily for six months before switching to the other type for an additional six months. The study seeks to provide scientific evidence to guide the prescription of compression garments, which currently lacks standardized guidelines. By comparing the two types of garments, the study hopes to identify any differences in their effectiveness and impact on symptoms.
Who should consider this trial
Good fit: Ideal candidates are women diagnosed with lipedema type III, stages 1 and 2, who have been using circular compression garments for at least six months.
Not a fit: Patients with lipedema that includes fatty lobulations, a BMI of 30 or higher, or other significant health issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved management strategies for patients with lipedema, enhancing their quality of life.
How similar studies have performed: This is the first study of its kind, aiming to provide new insights into the effectiveness of different compression garment types for lipedema.
Eligibility criteria
Show full inclusion / exclusion 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 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.
Where this trial is running
Valencia, Valencia
- Hospital Universitari i Politecnic La Fe — Valencia, Valencia, Spain (RECRUITING)
Study contacts
- Principal investigator: ISABEL FORNER-CORDERO, MD, PhD — Hospital Universitario La Fe
- Study coordinator: ISABEL FORNER-CORDERO, MD, PhD
- Email: ifornercordero@gmail.com
- Phone: +34649179852
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Lipedema, Compression garments, Maintenance treatment