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

NCT07125092 | Not Yet Recruiting

• 1 other identifier: EC46 LIP'EX
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Conditions

Lipoedema

Keywords

lipoedema; compression; pain; quality of life

Outcome Measures

Primary Outcomes (1)

• 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.

  Weekly between baseline and 8 weeks of follow-up

Secondary Outcomes (13)

• Evolution of pain threshold under pressure (algometer)

  From baseline to 8 weeks of follow-up

• Quality of life (QoL): Patient's opinion on Global Impression of Change (PGI-C)

  8 weeks

• Evolution of quality of life (QoL): the Patient Benefit Index (PBI-L)

  From baseline to 8 weeks of follow-up

• Evolution of lipedema-associated symptoms: Numeric Rating Scale (NRS)

  From baseline to 8 weeks of follow-up

• Evolution of limb volume : tape perimeter measurements

  From baseline to 8 weeks of follow-up

Study Arms (1)

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.

Device: compression group

Interventions

compression group DEVICE

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.

Compression group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Thuasne: lead

Study Sites (1)

La Fe University and Polytechnic Hospital

Valencia, Spain

Location

Related Publications (3)

• 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.

  PMID: 31062201 BACKGROUND

• Esmer 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.

  PMID: 33190432 BACKGROUND

• Forner-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.

  PMID: 33870676 BACKGROUND

Related Links

• Related Info

MeSH Terms

Conditions

Lipedema; Pain

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Isabel FORNER CORDERO, MD

CONTACT

961 24 40 00; fornrcordero@gmail.com

Astrid PICOLET

CONTACT

etudescliniques@thuasne.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This is a prospective, open-label, study conducted over a period of 10 weeks in a population of patients with lipedema

Study Record Dates

• First Submitted: July 28, 2025
• First Posted: August 15, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): October 30, 2026
• Last Updated: August 15, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)