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.
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.
Lipedema with fatty lobulations.
Body Mass Index (BMI) ≥ 30 kg/m2.
Waist-to-Height Ratio > 0.53.
Pregnancy.
Crossover
Flat-knitted compression garment
DeviceFlat knitted compression garments
Percentage of Volume Change (PVC)
The Percentage of Volume Change (PVC) at the 6th and 12th month of treatment is calculated using the following mathematical formula: PVC = \[ (Baseline volume- final volume)/ baseline volume\] x 100 Where: * Baseline is the reference volume at the beginning of the treatment. * Final Volume is the volume at the end of the treatment period (either at the 6th or 12th month). This calculation provides the percentage change in volume of the lower limbs over the course of the treatment period compared to the initial volume. We consider maintenance treatment is successful when the Percentage of Volume Change (PVC) is \<10% after 6 or 12 months of treatment, relative to the study's baseline. We define disease progression when the PVC is \>10% at 6 or 12 months, relative to the study's baseline.
Pain intensity
Pain in lower limbs: visual analogue scale (VAS). Scores range from 0 (absent) to 10 (worst possible).
Heaviness
Perceived heaviness in lower limbs: visual analogue scale (VAS). Scores range from 0 (absent) to 10 (worst possible).
Numbness
Numbness in lower limbs: visual analogue scale (VAS). Scores range from 0 (absent) to 10 (worst possible).
Characteristics of pain
Location and type of sensation.
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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
