Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 10:32 AM
Ignite Modification Date:
2025-12-26 @ 10:32 AM
NCT ID:
NCT06964828
Eligibility 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.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT06964828
Study Brief:
Protocol Section:
NCT06964828