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

N/ANot Yet RecruitingNCT07125092

Thuasne30 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Lipoedema

Interventions

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

La Fe University and Polytechnic Hospital

Valencia, Spain

Outcomes

Primary Outcomes

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

Secondary Outcomes

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.