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

Not Applicable

Not yet recruiting

• Conditions: Lipoedema

• Registration Number: NCT07125092
• Lead Sponsor: Thuasne

Brief 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.

Study Timeline

• Study First Submitted: 2025-07-28
• Status Verified: 2025-08
• Study First Submitted QC: 2025-08-08
• Last Update Submitted: 2025-08-08
• Study First Posted: 2025-08-15
• Last Update Posted: 2025-08-15
• Study Start: 2025-09-01
• Primary Completion: 2026-09-30
• Study Completion: 2026-10-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Evolution of pain: Numeric Rating Scale (NRS)	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.

Secondary Outcome Measures

Name	Time	Method
Evolution of pain threshold under pressure (algometer)	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.
Evolution of inflammatory biological biomarker : C-reactive protein	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
Evolution of fat distribution: Waist to hip ratio	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).
Device safety	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.
Compliance to treatment	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.
Quality of life (QoL): Patient's opinion on Global Impression of Change (PGI-C)	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.
Evolution of quality of life (QoL): the Patient Benefit Index (PBI-L)	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'.
Evolution of limb volume : tape perimeter measurements	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.
Evolution of weight: BMI	From baseline to 8 weeks of follow-up	The evolution of Body Mass Index (BMI) is calculated via the ratio Weight/(Size)2
Evolution of lipedema-associated symptoms: Numeric Rating Scale (NRS)	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
Garment pressure : PicoPress	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.
Evolution of skin tissue moisture : Moisture Meter	From baseline to 8 weeks of follow-up	Changes in skin tissue moisture content are assessed by the Moisture Meter (Delfin Technologies Ltd, Finland).
Satisfaction about the device	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).

Trial Locations

Locations (1)

La Fe University and Polytechnic Hospital; 🇪🇸 Valencia, Spain