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

Not Applicable

Recruiting

• Conditions: Lipedema

• Registration Number: NCT06964828
• Lead Sponsor: Isabel Forner-Cordero, MD, PhD

Brief Summary

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.

Detailed Description

Lipedema, described by Allen and Hines in 1940, is a syndrome characterized by painful edema in the lower limbs associated with a frequent occurrence of bruises. It mainly affects women and is usually symmetrical.

The management of patients depends on the stage and the presence of edema. In the maintenance phase, the goal is to prevent edema recurrence to avoid an increase in fat deposition in the lower limbs through the use of compression garments.

Currently, there are no guidelines for prescribing compression garments for patients with lipedema regarding the type of garment, fabric, or compression level. Therefore, the prescription by lymphologists is empirical and based on experience.

This study, the first of its kind, aims to assess the effectiveness and tolerance of circular and flat fabric garments in stabilizing the volume of the lower limbs and improving or stabilizing the signs and symptoms of patients with lipedema. The study also aims to determine if there are differences between the two types of garments currently used in routine clinical practice.

In order to provide scientific knowledge to guide these decisions, a prospective randomized crossover experimental study is proposed in patients with lipedema type III, stages 1 and 2, undergoing maintenance treatment with circular compression stockings for a minimum of 6 months. Patients meeting inclusion criteria will be randomized to continue receiving a compression garment with the same circular fabric they were wearing or alternatively switch to a compression garment with flat fabric, both for 6 months.

After 6 months, the study goals will be evaluated, and a simple crossover will be performed, switching to the other type of garment for another 6 months. In other words, patients wearing circular fabric garments will change to flat fabric compression garments and vice versa. At the end of the subsequent 6 months, the study goals will be reassessed once more.

To assess the study goals, we will record several variables related to:

* The effectiveness of circular and flat fabric garments

* Patient satisfaction with the garments

* Compliance with garment use

* Patient complaints about the garments

Therefore, patients will be recieve a follow-up visit at 6 months from the baseline assessment and at 6 months after crossover treatment. Garment usage will be assessed through automated calls every 2 weeks during the whole follow-up period.

Study Timeline

• Study Start: 2024-05-08
• Status Verified: 2025-05
• Study First Submitted: 2025-05-01
• Study First Submitted QC: 2025-05-08
• Study First Posted: 2025-05-09
• Last Update Submitted: 2025-05-09
• Last Update Posted: 2025-05-14
• Primary Completion: 2026-07
• Study Completion: 2026-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 34

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Percentage of Volume Change (PVC)	at the 6th and 12th month of treatment	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.

Secondary Outcome Measures

Name	Time	Method
Pain intensity	at the 6th and 12th month of treatment	Pain in lower limbs: visual analogue scale (VAS). Scores range from 0 (absent) to 10 (worst possible).
Numbness	at the 6th and 12th month of treatment	Numbness in lower limbs: visual analogue scale (VAS). Scores range from 0 (absent) to 10 (worst possible).
Heaviness	at the 6th and 12th month of treatment	Perceived heaviness in lower limbs: visual analogue scale (VAS). Scores range from 0 (absent) to 10 (worst possible).
Compliance	at the 6th and 12th months of treatment	Number of hours per day and days per week, wearing the compression garments
Reported Quality of Life	at the 6th and 12th months of treatment	LYMQOL (Lymphedema Quality of Life) questionnaire. Individual item scores range from 0 (least impact in quality of life or QOL) to 4 (maximum impact in QOL). Total scores may be calculated as a mean of all individual answers or as a percentage of the maximum possible score. The last question regarding overall quality of life is measured using the visual analogue scale (VAS) ranging from 0 (worst possible QOL) to 10 (best possible QOL).
Characteristics of pain	at the 6th and 12th month of treatment	Location and type of sensation.
Pressure pain threshold	at baseline, 6th and 12 th months.	Pressure pain threshold (PPT) will be assessed at the thigh using an algometer. Units: Newtons (N).

Trial Locations

Locations (1)

Hospital Universitari i Politecnic La Fe; 🇪🇸 Valencia, Spain