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

NCT ID: NCT04272827

Last Updated: 2025-03-19

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 450 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-15
• Study Completion Date: 2026-09-01

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).

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 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.

Conditions

Lipedema

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Intervention group

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.

Group Type: ACTIVE_COMPARATOR

Liposuction

Intervention Type: 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

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.

Group Type: OTHER

Liposuction

Intervention Type: 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.

Interventions

Liposuction

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.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

The Clinical Trials Centre Cologne

OTHER

Sponsor Role: collaborator

Hautklinik Darmstadt

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Maurizio Podda, Dr. med.

Role: STUDY_CHAIR

Hautklink Darmstadt

Locations

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

MVZ Praxis

Cologne, North Rhine-Westphalia, Germany

MVZ Praxis Dr. Cornely Düsseldorf MVZ Corius Nordrhein GmbH

Düsseldorf, North Rhine-Westphalia, Germany

Countries

Germany

References

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.

Reference Type: DERIVED

PMID: 34717741 (View on PubMed)

Other Identifiers

LIPLEG-3806

Identifier Type: -

Identifier Source: org_study_id