Status:
ACTIVE_NOT_RECRUITING
Evaluation Between Surgical Therapy of Lipedema Compared to Complex Physical Decongestive Therapy (CDT) Alone
Lead Sponsor:
Hautklinik Darmstadt
Collaborating Sponsors:
The Clinical Trials Centre Cologne
Conditions:
Lipedema
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
The purpose of this study is to determine whether surgical treatment of lipedema (stage I, II or III) using liposuction significantly improves leg pain compared to the use of complex decongestive ther...
Detailed Description
After being informed about the study and potential risks, all patients that gave written informed consent will undergo a run-in phase of up to seven months for edema elimination and maintenance of res...
Eligibility Criteria
Inclusion
- Signed informed consent form
- Female
- Age ≥ 18 years
- Confirmed lipedema of the legs in stage I, II or III
- Average pain in the legs for the last four weeks ≥ 4 points on a numerical rating scale
- Documentation of insufficient relief of symptoms by conservative measures
- Willingness and ability to perform conservative measures according to the study protocol, during and, if necessary, after liposuction treatment
- Full legal capacity
Exclusion
- 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
- Previous liposuctions
- 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
- Weight \>120.0 kg
- 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).
- Primary obesity without disproportion and without evidence of lipedema
- Secondary obesity
- Fat distribution disorders of other genesis (e.g. painless lipohypertrophy, benign symmetric lipomatoses or lipomatosis dolorosa)
- Other edema-causing diseases (such as lymphedema, phlebedema, or myxedema)
- Lack of willingness to ensure adequate contraception
- Positive pregnancy test
- Breastfeeding
- Use of a lymphomat
- Participation in other clinical studies
- Purely cosmetic reasons for participation in the study
Key Trial Info
Start Date :
January 15 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2026
Estimated Enrollment :
450 Patients enrolled
Trial Details
Trial ID
NCT04272827
Start Date
January 15 2021
End Date
September 1 2026
Last Update
March 19 2025
Active Locations (12)
Enter a location and click search to find clinical trials sorted by distance.
1
Praxis für Dermatologie, Dermatochirurgie und Phlebologie
Freiburg im Breisgau, Baden-Wurttemberg, Germany, 79098
2
Venenzentrum Freiburg
Freiburg im Breisgau, Baden-Wurttemberg, Germany, 79108
3
Universitätsklinikum Regensburg
Regensburg, Bavaria, Germany, 93053
4
Klinikum Ernst von Bergmann
Potsdam, Brandenburg, Germany, 14467