An interventional study of compression group in Lipoedema, sponsored by Thuasne. Not yet recruiting at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-08-15.
Sponsored by Thuasne · Not applicable, Interventional, and Treatment
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
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.
85 studies on the registry are indexed under Lipedema; 32 are open to participants now.
This study's planned enrollment of 30 is below the median of 35 across 42 interventional studies indexed under Lipedema.
Browse Lipedema studies →Thuasne is the lead sponsor of 21 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Evolution of pain: Numeric Rating Scale (NRS)
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.
Time frame: Weekly between baseline and 8 weeks of follow-up
Evolution of pain threshold under pressure (algometer)
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.
Time frame: From baseline to 8 weeks of follow-up
Quality of life (QoL): Patient's opinion on Global Impression of Change (PGI-C)
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.
Time frame: 8 weeks
Evolution of quality of life (QoL): the Patient Benefit Index (PBI-L)
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'.
Time frame: From baseline to 8 weeks of follow-up
Evolution of lipedema-associated symptoms: Numeric Rating Scale (NRS)
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
Time frame: From baseline to 8 weeks of follow-up
Evolution of limb volume : tape perimeter measurements
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.
Time frame: From baseline to 8 weeks of follow-up
Evolution of skin tissue moisture : Moisture Meter
Changes in skin tissue moisture content are assessed by the Moisture Meter (Delfin Technologies Ltd, Finland).
Time frame: From baseline to 8 weeks of follow-up
Garment pressure : PicoPress
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.
Time frame: Baseline and 8 weeks of follow-up
Evolution of inflammatory biological biomarker : C-reactive protein
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
Time frame: From baseline to 8 weeks of follow-up
Evolution of fat distribution: Waist to hip ratio
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).
Time frame: From baseline to 8 weeks of follow-up
Evolution of weight: BMI
The evolution of Body Mass Index (BMI) is calculated via the ratio Weight/(Size)2
Time frame: From baseline to 8 weeks of follow-up
Device safety
The safety of the device is assessed by describing the adverse events (AEs) and serious adverse events (SAEs) that occur throughout the study.
Time frame: From baseline to 10 weeks
Compliance to treatment
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.
Time frame: From baseline to 10 weeks
Satisfaction about the device
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).
Time frame: 8 weeks, 10 weeks
Plan to share: No
Start is estimated for Sep 2025; primary completion for Sep 2026, 12 months later.
Of 29 interventional studies with no phase under Lipedema, half reached primary completion within 15 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 31. This study's planned 12 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.
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