Evaluation Between Surgical Therapy of Lipedema Compared to Complex Physical Decongestive Therapy (CDT) Alone

NCT04272827 | Active Not Recruiting DMC

• 1 other identifier: LIPLEG-3806
• Study Type: interventional
• Target: 450
• Locations: 1 country
• Sites: 12

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 therapy (CDT).

Conditions

Lipedema

Keywords

Lipedema; complex decongestive therapy(CDT); liposuction

Outcome Measures

Primary Outcomes (1)

• Successful Pain Reduction After 12 Months (≥ 2 Points on a Numeric Rating Scale)

  The primary end point is the relevant reduction of the average pain of the last four weeks in the legs (≥ 2 points on a Numeric Rating Scale; German Pain Questionnaire) 12 months after completed liposuction treatment (intervention group) or after randomisation (control group) compared with the time of randomisation.

  12 months after completed liposuction treatment (intervention group) or after randomisation (control group) compared with the time of randomisation)

Secondary Outcomes (16)

• Change in Pain Severity as Assessed by German Pain Questionnaire

  12 months after completed liposuction treatment (intervention group) or after randomization (control group) compared with the time of randomisation)

• Change in Health-Related Quality of Life According to SF-36 Questionnaire

  12 months after completed liposuction treatment (intervention group) or after randomization (control group) compared with the time of randomisation)

• Change in Health-Related Quality of Life According to DLQI Questionnaire

  12 months after completed liposuction treatment (intervention group) or after randomisation (control group) compared with the time of randomisation)

• Change in Health-Related Quality of Life According to WHOQOL-BREF Questionnaire

  12 months after completed liposuction treatment (intervention group) or after randomisation (control group) compared with the time of randomisation)

• Change in Total Impairment According to Schmeller et al. (2010)

  12 months after completed liposuction treatment (intervention group) or after randomisation (control group) compared with the time of randomisation)

Study Arms (2)

Intervention group

ACTIVE COMPARATOR

In the intervention group, patients will receive liposuction treatment (number of surgeries at the discretion of the attending study physician: a maximum of 4 surgical procedures, with a minimum of 5 and a maximum of 7 weeks between each surgery) with concomitant complex decongestive therapy (CDT), if necessary, to maintain surgical outcomes as required by the patient.

Procedure: Liposuction

Control group

OTHER

After randomisation, the control group will be treated for 12 months with complex decongestive therapy (CDT) alone. After these 12 months, patients can opt for liposuction treatment if they continue to meet the inclusion and exclusion criteria.

Procedure: Liposuction

Interventions

Liposuction PROCEDURE

Liposuction treatment will be performed according to the study protocol using the "wet technique" depending on the amount of fat to be removed, if necessary in several sessions.

Control group; Intervention group

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Lipedema is a symmetrical, congenital, excessive increase in fatty tissue on the legs, which occurs almost exclusively in women.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hautklinik Darmstadt: lead
• The Clinical Trials Centre Cologne: collaborator

Study Sites (12)

Praxis für Dermatologie, Dermatochirurgie und Phlebologie

Freiburg im Breisgau, Baden-Wurttemberg, 79098, Germany

Location

Venenzentrum Freiburg

Freiburg im Breisgau, Baden-Wurttemberg, 79108, Germany

Location

Universitätsklinikum Regensburg

Regensburg, Bavaria, 93053, Germany

Location

Klinikum Ernst von Bergmann

Potsdam, Brandenburg, 14467, Germany

Location

Hautmedizin Bad Soden

Bad Soden am Taunus, Hesse, 65812, Germany

Location

Hautklinik Darmstadt

Darmstadt, Hesse, 64283, Germany

Location

Hautarztpraxis Mühltal

Mühltal, Hesse, 64367, Germany

Location

Evangelisches Krankenhaus Oldenburg Klinik für Plastische, Ästhetische, Rekonstruktive und Handchirurgie

Oldenburg, Lower Saxony, 26122, Germany

Location

Johanniter GmbH Waldkrankenhaus Bonn

Bonn, North Rhine-Westphalia, 53177, Germany

Location

Klinik und Praxisklinik für Plastische Chirurgie

Cologne, North Rhine-Westphalia, 50668, Germany

Location

MVZ Praxis

Cologne, North Rhine-Westphalia, 51069, Germany

Location

MVZ Praxis Dr. Cornely Düsseldorf MVZ Corius Nordrhein GmbH

Düsseldorf, North Rhine-Westphalia, 40474, Germany

Location

Related Publications (1)

• Podda M, Kovacs M, Hellmich M, Roth R, Zarrouk M, Kraus D, Prinz-Langenohl R, Cornely OA. A randomised controlled multicentre investigator-blinded clinical trial comparing efficacy and safety of surgery versus complex physical decongestive therapy for lipedema (LIPLEG). Trials. 2021 Oct 30;22(1):758. doi: 10.1186/s13063-021-05727-2.

  PMID: 34717741 DERIVED

MeSH Terms

Conditions

Lipedema

Interventions

Lipectomy

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Cosmetic Techniques; Therapeutics; Bariatric Surgery; Bariatrics; Obesity Management; Surgical Procedures, Operative; Plastic Surgery Procedures

Study Officials

• Maurizio Podda, Dr. med.

  Hautklink Darmstadt

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Random assignment of patients to one of the two treatment groups (experimental or controlled) is provided centrally via a 24/7 Internet service in ratio 2:1 (experimental: controlled) based on permuted blocks. The assignment is stratified to stage and centre.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: After a run in phase, randomization is performed in the intervention and control arm (2:1).

Study Record Dates

• First Submitted: February 12, 2020
• First Posted: February 17, 2020
• Study Start: January 15, 2021
• Primary Completion: August 31, 2024
• Study Completion (Estimated): September 1, 2026
• Last Updated: March 19, 2025

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

DE (12)