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

NCT ID: NCT06964828

Last Updated: 2025-05-14

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-08
• Study Completion Date: 2026-07-31

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.

Conditions

Lipedema

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Circular-knitted compression garments

The patient will continue using a compression garment with the same fabric she was wearing before inclusion (circular knitted pantyhose in class 2)

Group Type: ACTIVE_COMPARATOR

Flat-knitted compression garment

Intervention Type: DEVICE

Flat knitted compression garments

Flat-knitted compression garments

The patient will change to a flat-knitted pantyhose in class 2 for 6 months

Group Type: EXPERIMENTAL

Flat-knitted compression garment

Intervention Type: DEVICE

Flat knitted compression garments

Interventions

Flat-knitted compression garment

Flat knitted compression garments

Intervention Type: DEVICE

Other Intervention Names

Circular-knitted compression garment

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Hospital Provincial de Castellon

OTHER

Sponsor Role: collaborator

Hospital Arnau de Vilanova

OTHER

Sponsor Role: collaborator

Isabel Forner-Cordero, MD, PhD

OTHER

Sponsor Role: lead

Responsible Party

Isabel Forner-Cordero, MD, PhD

MD, PhD, Specialist in Physical Medicine and Rehabilitation, Associate professor of University of Valencia

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

ISABEL FORNER-CORDERO, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Hospital Universitario La Fe

Locations

Hospital Universitari i Politecnic La Fe

Valencia, Valencia, Spain

Site Status: RECRUITING

Countries

Spain

Central Contacts

ISABEL FORNER-CORDERO, MD, PhD

Role: CONTACT

ifornercordero@gmail.com

+34649179852

Facility Contacts

Isabel Forner-Cordero, PhD

Role: primary

ceic@iislafe.es

+34 96 124 66 05

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Other Identifiers

LipeGar

Identifier Type: -

Identifier Source: org_study_id