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NCT07125092
NA

A Study to Evaluate the Clinical Benefit and Safety of Medical Compression Garments in the Management of Patients With Lipedema

Sponsor: Thuasne

View on ClinicalTrials.gov

Summary

Lipedema (LI) is a chronic condition, painful disease characterized by a disproportionate increase in adipose tissue and pain in women's legs and sometimes arms. Its prevalence is largely unknown, but lipedema is estimated to affect 0.06% to 11% of the female population. Even though this pathology is increasingly studied and working groups are collaborating to harmonize criteria, a crucial underlying problem of lipedema is the variability in identifying lipedema. Lipedema patients often suffer from obesity, physical disability and psychological impairments, and the effects on quality of life are significant. Almost all women with lipedema are dissatisfied with the disproportionality of their body and the stigma associated with it. In addition to weight gain, pain is one of the major symptoms of this pathology, but also limb heaviness, weakness, or difficulties with walking. Patients also tend to develop easy bruising, although these symptoms are not always present. Treatment of lipedema is aimed at relieving pain, maintaining/improving mobility, reducing volume of the limbs, and improving quality of life. It is important to note that compression therapy is one of the cornerstones of this treatment because of its anti-inflammatory effect on adipose tissue

Official title: A Study to Evaluate the Clinical Benefit and Safety of Medical Compression Garments in the Management of Patients With Lipœdema

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

30

Start Date

2025-09-01

Completion Date

2026-10-30

Last Updated

2025-08-15

Healthy Volunteers

No

Conditions

Interventions

DEVICE

compression group

All patients enrolled in the study will be instructed to wear the compression garment for 8 weeks, as long as possible during the day. In parallel, all patients will receive the same advice about routine care: physical exercises, nutrition aspect that are part of the centre's current practice. 3 study visits are planned: the inclusion visit (V0) includes patient information and consent signature, measurements for custom-made compression stockings. The initial visit (V1) includes devices collection and fitting, patient questionnaires, physician assessment (medical and lipedema history, BMI, WHtR, blood sample collection, pain description, lipedema associated symptoms, leg perimeter measurements, Moisture Meter, pressure under the garment). The follow-up visit (V2) after 8 weeks includes: patient questionnaires and physician assessment. After 8 weeks, another compression garment will be given to the patient with a new satisfaction e-questionnaire at 10 weeks of follow-up.

Locations (1)

La Fe University and Polytechnic Hospital

Valencia, Spain