Evaluation Between Surgical Therapy of Lipedema Compared to Complex Physical Decongestive Therapy (CDT) Alone
Sponsored by Hautklinik Darmstadt
About this trial
Last updated 3 years ago
Study ID
Status
Type
Phase
Placebo
Accepting
Not accepting
Trial Timing
Started 5 years ago
What is this trial about?
What are the participation requirements?
Inclusion Criteria
1. Signed informed consent form
2. Female
3. Age ≥ 18 years
4. Confirmed lipedema of the legs in stage I, II or III
5. Average pain in the legs for the last four weeks ≥ 4 points on a numerical rating scale
6. Documentation of insufficient relief of symptoms by conservative measures
7. Willingness and ability to perform conservative measures according to the study protocol, during and, if necessary, after liposuction treatment
8. Full legal capacity
Exclusion Criteria
1. Concurrent lipedema of the arms and legs, in which co-occurrence of lipedema in the arms affects the primary endpoint (i.e., average leg pain), at the discretion of the study investigator
2. Previous liposuctions
3. Diseases that may limit operability at the discretion of the study physician, e.g. cardiac diseases, coagulation disorders, metabolic diseases, infectious diseases (active), epilepsy; diseases requiring immunosuppression or anticoagulation with medication; allergies to medication accompanying surgery
4. Weight >120.0 kg
5. Medical conditions that affect adequate complex decongestive therapy (CDT) at the discretion of the study physician, e.g. heart failure (volume stress), lack of physical ability to wear compression stockings (e.g. joint disease, neurological deficits).
6. Primary obesity without disproportion and without evidence of lipedema
7. Secondary obesity
8. Fat distribution disorders of other genesis (e.g. painless lipohypertrophy, benign symmetric lipomatoses or lipomatosis dolorosa)
9. Other edema-causing diseases (such as lymphedema, phlebedema, or myxedema)
10. Lack of willingness to ensure adequate contraception
11. Positive pregnancy test
12. Breastfeeding
13. Use of a lymphomat
14. Participation in other clinical studies
15. Purely cosmetic reasons for participation in the study