E88.22
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Women between 18 and 70 years of age with a clinically confirmed diagnosis (Group I: lipedema, Group II: lipohypertrophy, Group III: lymphedema) or exclusion of these diagnoses (control group, Group IV).
Exclusion criteria
Exclusion criteria: • Saphenous vein insufficiency (excluded by investigator beforehand by ultrasound) • Diabetic neuropathy • Use of edema-inducing antihypertensive medication (in particular amlodipine and ramipril) • Pregnancy (not due to any risk to the pregnant woman or the unborn child, but due to the possible influence on edema formation) • Lack of capacity to provide informed consent • Insufficient ability to communicate in German • Participation in other studies within the last 4 weeks.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Discriminative identification of the disease performed by Statistical recording of the optimal method for discrimination between lipedema, lipohypertrophy, and lymphedema. After collection of all previously known measurement methods (see points 1–11 of the description in the study groups), these will be statistically evaluated in order to identify the method that best differentiates between the 4 clinical pictures. Data collection takes place during the 90 minutes of the subject’s presence; the evaluation is then carried out by the statistician afterward. | — |
Secondary
| Measure | Time frame |
|---|---|
| Quantification of the severity of the different diseases by Correlations between measurement values and severity of the disease The severity of the disease is defined by the questionnaires (see 1). The scores of the questionnaires are statistically correlated with the results of the individual measurements in order to determine whether any of the measurements (2, 3, 5–11) can objectively capture the severity of the disease most accurately. | — |
Countries
Germany
Contacts
Venenpraxis Wunstorf