LipoedemaLIP'EXNCT07125092
A Study to Evaluate the Clinical Benefit and Safety of Medical Compression Garments in the Management of Patients With Lipedema
A study testing compression group in people with Lipoedema, run by Thuasne at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lipoedema
- What is being tested?
- compression group
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSpain
- Study dates
- 1 Sep 2025to 30 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Astrid PICOLET contact
Spain1 site
La Fe University and Polytechnic Hospital
Valencia
Isabel FORNER CORDERO, MD, 961 24 40 00 ext. +34, fornrcordero@gmail.com
About this study
Official title: 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
Read the 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
- Being tested
- compression group
- Keywords
- lipoedema, compression, pain, quality of life
- Medical subject headings
- Lipedema, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
compression groupDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Compression group | Experimental | 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. Receives: Device: compression group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Weekly between baseline and 8 weeks of follow-up
Secondary outcomes (13)
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.
Measured: 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.
Measured: 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'.
Measured: 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
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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
Measured: 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).
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 8 weeks, 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2025
- Study start1 Sep 2025 (estimated)
- Primary completion30 Sep 2026 (estimated)
- Study completion30 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for LipoedemaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a prospective, open-label, study conducted over a period of 10 weeks in a population of patients with lipedema
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Thuasne
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07125092
- Sponsor's protocol ID
- EC46 LIP'EX
- Acronym
- LIP'EX
- Status last verified
- Aug 2025
- First submitted
- 28 Jul 2025
- Last updated
- 15 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Alwardat N, Di Renzo L, Alwardat M, Romano L, De Santis GL, Gualtieri P, Carrano E, Nocerino P, De Lorenzo A. The effect of lipedema on health-related quality of life and psychological status: a narrative review of the literature. Eat Weight Disord. 2020 Aug;25(4):851-856. doi: 10.1007/s40519-019-00703-x. Epub 2019 May 6.
PubMed 31062201Esmer M, Schingale FJ, Unal D, Yazici MV, Guzel NA. Physiotherapy and rehabilitation applications in lipedema management: A literature review. Lymphology. 2020;53(2):88-95.
PubMed 33190432Forner-Cordero I, Forner-Cordero A, Szolnoky G. Update in the management of lipedema. Int Angiol. 2021 Aug;40(4):345-357. doi: 10.23736/S0392-9590.21.04604-6. Epub 2021 Apr 19.
PubMed 33870676
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Evaluate the Clinical Benefit and Safety of Medical Compression Garments in the Management of Patients With Lipœdema
- ClinicalTrials.gov ID
- NCT07125092
- Acronym / sponsor ID
- LIP'EX / EC46 LIP'EX
- Conditions
- Lipoedema
- Keywords
- lipoedema, compression, pain, quality of life
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- ThuasneIndustry (pharma, biotech, devices)
- Study start
- 1 Sep 2025 (estimated)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 30 Oct 2026 (estimated)
- First posted
- 15 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a prospective, open-label, study conducted over a period of 10 weeks in a population of patients with lipedema
| Arm | Type | Receives |
|---|---|---|
| Compression group | Experimental | Device: compression groupCompression 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (10 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| compression groupAll 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. | Device | Compression group |
Primary outcome
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.
13 secondary outcomes
Evolution of pain threshold under pressure (algometer)
Time frame: 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
Evolution of quality of life (QoL): the Patient Benefit Index (PBI-L)
Time frame: 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
Evolution of limb volume : tape perimeter measurements
Time frame: 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
Garment pressure : PicoPress
Time frame: 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
Evolution of fat distribution: Waist to hip ratio
Time frame: From baseline to 8 weeks of follow-up
Evolution of weight: BMI
Time frame: From baseline to 8 weeks of follow-up
Device safety
Time frame: From baseline to 10 weeks
Compliance to treatment
Time frame: From baseline to 10 weeks
Satisfaction about the device
Time frame: 8 weeks, 10 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2025.
- Background: PubMed 31062201Alwardat N, Di Renzo L, Alwardat M, Romano L, De Santis GL, Gualtieri P, Carrano E, Nocerino P, De Lorenzo A. The effect of lipedema on health-related quality of life and psychological status: a narrative review of the literature. Eat Weight Disord. 2020 Aug;25(4):851-856. doi: 10.1007/s40519-019-00703-x. Epub 2019 May 6.
- Background: PubMed 33190432Esmer M, Schingale FJ, Unal D, Yazici MV, Guzel NA. Physiotherapy and rehabilitation applications in lipedema management: A literature review. Lymphology. 2020;53(2):88-95.
- Background: PubMed 33870676Forner-Cordero I, Forner-Cordero A, Szolnoky G. Update in the management of lipedema. Int Angiol. 2021 Aug;40(4):345-357. doi: 10.23736/S0392-9590.21.04604-6. Epub 2021 Apr 19.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Astrid PICOLET contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing compression group in people with Lipoedema, run by Thuasne at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 15 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Isabel FORNER CORDERO, MD (961 24 40 00 ext. +34, fornrcordero@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evolution of pain: Numeric Rating Scale (NRS) (time frame: Weekly between baseline and 8 weeks of follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07125092, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2025.