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

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT07125092
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Thuasne
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Industry
Overall Status Not yet recruiting
Countries Spain
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Lipoedema
Study Website: View Trial Website
Additional Details

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.

Arms & Interventions

Arms

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.

Interventions

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Valencia 2509954, Spain

Status

Address

La Fe University and Polytechnic Hospital

Valencia 2509954, ,

Site Contact

Isabel FORNER CORDERO, MD

[email protected]

961 24 40 00 #+34

Nearest Location

Site Contact

Isabel FORNER CORDERO, MD

[email protected]

961 24 40 00 #+34

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The content provided in the Lipedema Foundation Legwork program is for informational purposes and does not, under any circumstance, constitute medical advice. Consult with your healthcare provider regarding any changes to your lipedema treatment including participation in any study. Information provided here is maintained by the TrialScope vendor and supplied by the individual study teams. Use of the TrialScope service requires acceptance of the TrialScope privacy policy and terms of service. Some features of the service may require registration of the user's contact information with TrialScope through the TrialScope website. Do not register if you do not consent to providing such information. The Lipedema Foundation does not guarantee that the contents are accurate or complete, or that any given study will be available for participation or applicable to your condition. The listing of a study on the site does not constitute an endorsement or recommendation of that study by the Lipedema Foundation. As such, you hereby waive claims and liability against the Lipedema Foundation for any harm, including bodily injury and death, that may result in connection with the use of this service. The Lipedema Foundation reserves the right, at its discretion, to omit studies or add studies to the service without notice. The Lipedema Foundation does not represent that the list of studies presented through the service is complete.

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