A Study to Evaluate the Clinical Benefit and Safety of Medical Compression Garments in the Management of Patients With Lipœdema
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Thuasne
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Evolution of pain: Numeric Rating Scale (NRS)
Study Overview
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
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
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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,
- •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.
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Evolution of pain threshold under pressure (algometer)(From baseline to 8 weeks of follow-up)
- Evolution of inflammatory biological biomarker : C-reactive protein(From baseline to 8 weeks of follow-up)
- Evolution of fat distribution: Waist to hip ratio(From baseline to 8 weeks of follow-up)
- Device safety(From baseline to 10 weeks)
- Compliance to treatment(From baseline to 10 weeks)
- 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 limb volume : tape perimeter measurements(From baseline to 8 weeks of follow-up)
- Evolution of weight: BMI(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)
- Garment pressure : PicoPress(Baseline and 8 weeks of follow-up)
- Evolution of skin tissue moisture : Moisture Meter(From baseline to 8 weeks of follow-up)
- Satisfaction about the device(8 weeks, 10 weeks)