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

Official title

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

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

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.

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 collect

Primary outcome measures

• Evolution of pain: Numeric Rating Scale (NRS) [Time frame: Weekly between baseline and 8 weeks of follow-up]

Secondary outcome measures (12)

• 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]

Eligibility 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

Spain · 1 center

• La Fe University and Polytechnic Hospital — Valencia

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. PMID 31062201
• 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
• 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

Identifiers

NCT: NCT07125092 · EC46 LIP'EX

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗