NCT07125092

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

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Thuasne · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Detailed description

Wearing compression stockings leads to a significant reduction in oxidative stress, a finding that also indicates improved microcirculation in the subcutaneous tissue. Wearing compression stockings may relieve pain and may improve the ability of patients to move. In this context, the hypothesis is that the treatment of lipedema patients with compression stockings contributes to the reduction of lipedema-associated symptoms such as pain and heaviness and thus contributes to a better quality of life.

Conditions

• Lipoedema

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-09-01
• Primary completion: 2026-09-30
• Completion: 2026-10-30
• First posted: 2025-08-15
• Last updated: 2025-08-15

Locations

1 site across 1 country: Spain