E88.20 E88.21 E88.22
Conditions
Interventions
Group 1: This is a prospective, single-arm exploratory study. Twenty women with lipedema who are already receiving compression therapy will be switched to a flat-knit compression garment (CuraFlow®, B
Sponsors
Venenpraxis Wunstorf
Eligibility
Sex/Gender
Female
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: Women with lipedema who have been using compression therapy for at least one year, provided that their current compression garment is not the study product Willingness to wear the study product (two sets of compression garments) as the sole compression therapy for four weeks
Exclusion criteria
Exclusion criteria: Active malignancy Diabetic neuropathy Exudative skin disorders of the lower extremities or active infections Pregnancy (not because of any anticipated risk to the mother or the unborn child, but due to the potential influence of pregnancy on oedema formation) Severe comorbid conditions whose symptoms may substantially interfere with the assessment of lipedema-related pain (e.g. recent hip surgery or severe pain caused by lumbar spine disorders) Inability to provide informed consent Insufficient proficiency in the German language to understand study information and complete study questionnaires Participation in another clinical study within the previous four weeks
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is assessed using a study-specific questionnaire based on a 0–10 numerical rating scale. Participants' evaluations of their existing compression garment are compared with their evaluations of the study garment after four weeks of use. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints include changes in pain intensity after four weeks, changes in diagnostic findings such as tenderness on palpation and the presence of concomitant lymphoedema, as well as patient compliance and adherence to compression therapy. | — |
Countries
Germany
Contacts
Public ContactErika Mendoza
Venenpraxis Wunstorf
Outcome results
None listed