A Study to Evaluate the Clinical Benefit and Safety of Medical Compression Garments in the Management of Patients With Lipedema (LIP'EX)

August 8, 2025 updated by: Thuasne

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

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Spain
      • Valencia, Spain
        • La Fe University and Polytechnic Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Lipedema diagnosed at least in the legs according to the initial Wold criteria modified by Herbst.
  • Average pain in the legs over the last week ≥ 4 points on a 10 points Numerical Rating Scale visual analogue scale.
  • Patient who has given his informed consent freely and signed it prior to any intervention in the study.

Exclusion Criteria:

  • Patient for whom compression is contraindicated, such as untreated infections, skin irritation or lesions.
  • Lipedema type I: Hips/buttocks.
  • Patients who underwent liposuction.
  • Patient with a WHtR higher than 0,58.
  • Patient with active cancer, chemotherapy treatment, chronic inflammatory disease, chronic anti-inflammatory therapy (ex: TNF alpha).
  • Patient with surgery scheduled/planned during the study period.
  • Patient with a known allergy to the components used in the devices.
  • Pregnant woman or woman of childbearing age without contraception.
  • Patient currently participating in another clinical investigation that could impact the study endpoints.
  • Patient with psychiatric, psychological, or neurological disorders that are incompatible with the proper follow-up of the clinical investigation.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Compression group

Compression device 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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evolution of pain: Numeric Rating Scale (NRS)
Time Frame: Weekly between baseline and 8 weeks of follow-up
The evolution of perceived leg pain (mean and maximum) related to lipedema is measured by Numeric Rating Scale (NRS). 0 corresponds to no pain and 10 to the maximum pain.
Weekly between baseline and 8 weeks of follow-up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evolution of pain threshold under pressure (algometer)
Time Frame: From baseline to 8 weeks of follow-up
The pain threshold under pressure is measured by an algometer. It is a non-invasive and painless instrument that consists of a dial, a cylinder attached to the dial, and a rod inside the cylinder, which ends in a 1 cm2 rubber tip.
From baseline to 8 weeks of follow-up
Quality of life (QoL): Patient's opinion on Global Impression of Change (PGI-C)
Time Frame: 8 weeks

The patient's impression of overall change is measured by the Patient's opinion on Global Impression of Change questionnaire (PGI-C). The scale has 7 levels of response :

"no change or condition has got worse" that is the worst outcome (= 1 point) "almost the same, hardly any change at all" (= 2 points); "a little better , but no noticeable change" (= 3 points); "somewhat better, but the change has not made any real difference" (= 4 points); "moderately better, and a slight but noticeable change" (= 5 points); "better, and a definite improvement that has made a real and worthwhile difference (=6 points); "A great deal better, and a considerable improvement that has made all the diiference" (=7 points).

The highest score corresponds to the most improvement in quality of life.
8 weeks
Evolution of quality of life (QoL): the Patient Benefit Index (PBI-L)
Time Frame: From baseline to 8 weeks of follow-up
The evolution of QoL related to the lipedema is measured by the PBI-L self-questionnaire. It consists of 23 questions about different area: quality of life, physical, psychological. It consists of 2 questionnaires : before therapy and after therapy. The patient rates the extent to which the treatment objectives have been achieved. Questions are scaled from 0 'not important at all' to 4 'very important' with a response option 'does not apply to me'.
From baseline to 8 weeks of follow-up
Evolution of lipedema-associated symptoms: Numeric Rating Scale (NRS)
Time Frame: From baseline to 8 weeks of follow-up
The evolution of swelling, tightness, discomfort, heaviness, skin suppleness, fatigue due to lipedema is measured by NRS : 0 corresponds to no symptom and 10 to maximum symptom
From baseline to 8 weeks of follow-up
Evolution of limb volume : tape perimeter measurements
Time Frame: From baseline to 8 weeks of follow-up
The evolution of limb volume is measured by tape perimeter measurements taken from the dorsum of the foot and repeated for every 4 cm proximally until the root of the limb.
From baseline to 8 weeks of follow-up
Evolution of skin tissue moisture : Moisture Meter
Time Frame: From baseline to 8 weeks of follow-up
Changes in skin tissue moisture content are assessed by the Moisture Meter (Delfin Technologies Ltd, Finland).
From baseline to 8 weeks of follow-up
Garment pressure : PicoPress
Time Frame: Baseline and 8 weeks of follow-up
The pressure under the garment is measured by the Picopress. The PicoPress instrument is a portable digital gauge that measures the pressure exerted by a garment. The pressure detected by the transducer is displayed in Newton.
Baseline and 8 weeks of follow-up
Evolution of inflammatory biological biomarker : C-reactive protein
Time Frame: From baseline to 8 weeks of follow-up
The evolution of inflammatory biological biomarker : C-reactive protein (CRP) is measured from blood sample collection. The rate will be evaluated in milligrams per liter
From baseline to 8 weeks of follow-up
Evolution of fat distribution: Waist to hip ratio
Time Frame: From baseline to 8 weeks of follow-up
The evolution of fat distribution is calculated via the Waist-to-hip Ratio (WHR= waist circumference / hip circumference) and the Waist-to-Height-Ratio (WHtR= waist circumference / height).
From baseline to 8 weeks of follow-up
Evolution of weight: BMI
Time Frame: From baseline to 8 weeks of follow-up
The evolution of Body Mass Index (BMI) is calculated via the ratio Weight/(Size)2
From baseline to 8 weeks of follow-up
Device safety
Time Frame: From baseline to 10 weeks
The safety of the device is assessed by describing the adverse events (AEs) and serious adverse events (SAEs) that occur throughout the study.
From baseline to 10 weeks
Compliance to treatment
Time Frame: From baseline to 10 weeks
The compliance to treatment (day and night) is reported by the physician according to the patient diary. The compliance is measured in average number of days that the device is worn.
From baseline to 10 weeks
Satisfaction about the device
Time Frame: 8 weeks, 10 weeks
Patient's satisfaction with regards to the device is measured by a specific self-questionnaire given to the patient. The questionnaire is mainly focused on product positioning, comfort, stiffness with a 4 level-answer (example: very satisfied, satisfied, unsatisfied, very unsatisfied).
8 weeks, 10 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Thuasne

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 1, 2025

Primary Completion (Estimated)

September 30, 2026

Study Completion (Estimated)

October 30, 2026

Study Registration Dates

First Submitted

July 28, 2025

First Submitted That Met QC Criteria

August 8, 2025

First Posted (Estimated)

August 15, 2025

Study Record Updates

Last Update Posted (Estimated)

August 15, 2025

Last Update Submitted That Met QC Criteria

August 8, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EC46 LIP'EX

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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