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Multicentre, Controlled, Randomized, Investigator-blinded Clinical Trial on Efficacy and Safety of Surgical Therapy of Lipedema Compared to Complex Physical Decongestive Therapy Alone (LIPLEG)
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 therapy (CDT).
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 results using complex decongestive therapy (CDT). Afterwards, patients will be assigned to one of the two treatment groups via internet randomization, provided that all inclusion and exclusion criteria continue to be met. Randomization will be 2:1 (intervention: control). In the intervention arm, patients will receive liposuction treatment (number of surgeries at the discretion of the treating study physician: a maximum of four surgical procedures, with a minimum of 5 and a maximum of 7 weeks between each surgery) with, if necessary, concomitant CDT to maintain the surgical results as required by the patient. The primary endpoint (regarding pain in the legs in stages I, II or III) will be assessed after an observation period of 12 months after final liposuction surgery. This is followed by a further follow-up period for 24 months to observe and document the further course.
Age
18 - No limit years
Sex
FEMALE
Healthy Volunteers
No
Praxis für Dermatologie, Dermatochirurgie und Phlebologie
Freiburg im Breisgau, Baden-Wurttemberg, Germany
Venenzentrum Freiburg
Freiburg im Breisgau, Baden-Wurttemberg, Germany
Universitätsklinikum Regensburg
Regensburg, Bavaria, Germany
Klinikum Ernst von Bergmann
Potsdam, Brandenburg, Germany
Hautmedizin Bad Soden
Bad Soden am Taunus, Hesse, Germany
Hautklinik Darmstadt
Darmstadt, Hesse, Germany
Hautarztpraxis Mühltal
Mühltal, Hesse, Germany
Evangelisches Krankenhaus Oldenburg Klinik für Plastische, Ästhetische, Rekonstruktive und Handchirurgie
Oldenburg, Lower Saxony, Germany
Johanniter GmbH Waldkrankenhaus Bonn
Bonn, North Rhine-Westphalia, Germany
Klinik und Praxisklinik für Plastische Chirurgie
Cologne, North Rhine-Westphalia, Germany
Start Date
January 15, 2021
Primary Completion Date
August 31, 2024
Completion Date
September 1, 2026
Last Updated
March 19, 2025
450
ESTIMATED participants
Liposuction
PROCEDURE
Lead Sponsor
Hautklinik Darmstadt
Collaborators
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT05739279