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

Lipedema Clinical Trial

— LIPLEG  

Official title:

Multicentre, Controlled, Randomized, Investigator-blinded Clinical Trial on Efficacy and Safety of Surgical Therapy of Lipedema Compared to Complex Physical Decongestive Therapy Alone (LIPLEG)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04272827
• Other study ID #: LIPLEG-3806
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 15, 2021
• Est. completion date: September 1, 2026

Study information

• Verified date: October 2023
• Source: Hautklinik Darmstadt
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 450
• Est. completion date: September 1, 2026
• Est. primary completion date: August 31, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lipedema

Intervention

Procedure:
• 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.

Locations

Country	Name	City	State
Germany	Hautmedizin Bad Soden	Bad Soden am Taunus	Hessen
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	Hautklinik Darmstadt	Darmstadt	Hessen
Germany	MVZ Praxis Dr. Cornely Düsseldorf MVZ Corius Nordrhein GmbH	Düsseldorf	NRW
Germany	Praxis für Dermatologie, Dermatochirurgie und Phlebologie	Freiburg	Baden-Württemberg
Germany	Venenzentrum Freiburg	Freiburg	Baden-Württemberg
Germany	Hautarztpraxis Mühltal	Mühltal	Hessen
Germany	Evangelisches Krankenhaus Oldenburg Klinik für Plastische, Ästhetische, Rekonstruktive und Handchirurgie	Oldenburg	Lower Saxony
Germany	Klinikum Ernst von Bergmann	Potsdam	Brandenburg
Germany	Universitätsklinikum Regensburg	Regensburg	Bavaria

Sponsors (2)

Lead Sponsor	Collaborator
Hautklinik Darmstadt	The Clinical Trials Centre Cologne

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change in Pain Severity as Assessed by German Pain Questionnaire	Change in severity according to von Korff et al. (1992) regarding pain in the legs (stage I, II or III). The severity is calculated based on the questions of the German Pain Questionnaire according to von Korff et al (1992). The assessment of the pain intensity as well as the impairment and information on the days of impairment are included in the calculation of the severity (classes 0 = no pain to 4 = high, pain-related impairment, strongly limiting).	12 months after completed liposuction treatment (intervention group) or after randomization (control group) compared with the time of randomisation)
Secondary	Change in Health-Related Quality of Life According to SF-36 Questionnaire	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)
Secondary	Change in Health-Related Quality of Life According to DLQI Questionnaire	Change in health-related quality of life according to DLQI questionnaire (a clinically relevant change corresponds to = 4 points change in DLQI sum score).	12 months after completed liposuction treatment (intervention group) or after randomisation (control group) compared with the time of randomisation)
Secondary	Change in Health-Related Quality of Life According to WHOQOL-BREF Questionnaire	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)
Secondary	Change in Total Impairment According to Schmeller et al. (2010)	Total impairment is measured by taking the mean of 7 numerical rating scales assessing the domains pain (spontaneous, pressure), swelling, hematoma, movement, cosmetic appearance and quality of life (0 (none) - 10 (always/very strong) points), see Schmeller et al. (2010).	12 months after completed liposuction treatment (intervention group) or after randomisation (control group) compared with the time of randomisation)
Secondary	Altered Depression Tendency According to PHQ-9 Questionnaire	Altered depression tendency according to PHQ-9 questionnaire (a clinically relevant improvement corresponds to = 5 points reduction in PHQ-9 sum score).	12 months after completed liposuction treatment (intervention group) or after randomisation (control group) compared with the time of randomisation)
Secondary	Altered Hematoma Tendency According to Schmeller et al. (2010)	Hematoma ("Are you prone to bruising?") is measured by a numerical rating scale (0 (none) - 10 (always/very strong) points), see Schmeller et al. (2010).	12 months after completed liposuction treatment (intervention group) or after randomisation (control group) compared with the time of randomisation)
Secondary	Changed Prevalence of Edema	Changed prevalence of edema	12 months after completed liposuction treatment (intervention group) or after randomisation (control group) compared with the time of randomisation)
Secondary	Change in the Scope of the Physical Therapy	The scope of the physical therapy is measured by the number of treatment sessions per month.	12 months after completed liposuction treatment (intervention group) or after randomisation (control group) compared with the time of randomisation)
Secondary	Change in Body Fat Percentage According to Wright et al. (1981)	Change in body fat percentage, determined according to formula from Wright et al. (1981), collected by means of measuring tape at the following points: abdominal circumference: measurement at the level of the navel. The tape measure is placed horizontally around the body; neck circumference: measurement below the larynx; body size; hip circumference: the widest part of the hip is measured.	12 months after completed liposuction treatment (intervention group) or after randomisation (control group) compared with the time of randomisation)
Secondary	Change of Leg Circumference by Means of Measuring Tape	Change of leg circumference of the left and right leg by means of measuring tape at five specified measuring points: lower leg cuffs; calf center; knee; 10 cm below the groin; hips (iliac crest).	12 months after completed liposuction treatment (intervention group) or after randomisation (control group) compared with the time of randomisation)
Secondary	Movement Restriction Reduction According to LEFS Sum Score	Relevant reduction in movement restriction (stage I, II, or III; = 9 points improvement in LEFS sum score)	12 months after completed liposuction treatment (intervention group) or after randomisation (control group) compared with the time of randomisation)
Secondary	Number of Recurrent Interventions	Number of recurrent interventions	12 months after completed liposuction treatment (intervention group) or after randomisation (control group) compared with the time of randomisation)
Secondary	Number of (Serious) Adverse Events	Number of (serious) adverse events	12 months after completed liposuction treatment (intervention group) or after randomisation (control group) compared with the time of randomisation)
Secondary	Number of Therapy Interruptions Caused by Adverse Events	Discontinuation of therapy caused by adverse events	12 months after completed liposuction treatment (intervention group) or after randomisation (control group) compared with the time of randomisation)
Secondary	Optional: Change of the Leg Volume by Means of Perometry	Optional: Change of the leg volume of the left and right leg (e.g. by means of perometry etc.)	12 months after completed liposuction treatment (intervention group) or after randomisation (control group) compared with the time of randomisation)