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

ConditionLipedema
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-70
SponsorIsabel Forner-Cordero, MD, PhD

About this trial

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 criteria

Qualifiers

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.

Disqualifiers

Lipedema with fatty lobulations.

Body Mass Index (BMI) ≥ 30 kg/m2.

Waist-to-Height Ratio > 0.53.

Pregnancy.

Trial design

Treatments tested in this trial

  • Flat-knitted compression garment

Treatment groups

34 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Isabel Forner-Cordero, MD, PhD

Lead sponsor

Instituto de Investigacion Sanitaria La Fe

Sponsor institution

Hospital Provincial de Castellon

Collaborator

Hospital Arnau de Vilanova

Collaborator