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Search / Trial NCT06964828

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

Launched by ISABEL FORNER-CORDERO, MD, PHD · May 8, 2025

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Lipedema Compression Garments Maintenance Treatment

ClinConnect Summary

This clinical trial is looking to understand how effective two types of compression garments—circular and flat knitted pantyhose—are for women with lipedema, a condition that causes painful swelling in the legs. The study will involve women aged 25 to 65 who have been diagnosed with lipedema and have been using a specific type of compression garment for at least six months. Participants will wear one type of garment for six months, then switch to the other type for another six months to see if there is any difference in how well they work to reduce swelling and improve comfort.

To be eligible for this trial, women must have a clear diagnosis of lipedema with specific characteristics, such as swelling in the lower limbs and pain, and they need to be in a stable phase of treatment. Those with certain health conditions, like obesity or heart issues, or those who are pregnant, cannot participate. If you join the trial, you'll be helping researchers learn more about how these garments can help manage lipedema, and you may benefit from trying a new type of garment that could improve your comfort and quality of life.

Gender

FEMALE

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.

About Isabel Forner Cordero, Md, Phd

Isabel Forner-Cordero, MD, PhD, is a distinguished clinical trial sponsor known for her expertise in advancing medical research and enhancing patient care. With a robust background in clinical medicine and research, Dr. Forner-Cordero leads innovative trials aimed at developing new therapeutic strategies and improving treatment outcomes across various medical disciplines. Her commitment to rigorous scientific standards and patient-centered approaches fosters collaboration among multidisciplinary teams, ensuring that clinical studies not only meet regulatory requirements but also prioritize participant safety and efficacy. Dr. Forner-Cordero’s contributions are pivotal in bridging the gap between laboratory discoveries and clinical application, ultimately driving progress in healthcare.

Locations

Valencia, , Spain

Patients applied

0 patients applied

Trial Officials

ISABEL FORNER-CORDERO, MD, PhD

Principal Investigator

Hospital Universitario La Fe

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported