Back to resultsEvaluation Between Surgical Therapy of Lipedema Compared to Complex Physical Decongestive Therapy (CDT) Alone (LIPLEG)
Primary Purpose
Lipedema
Status
Active
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Liposuction
Sponsored by
About this trial
This is an interventional treatment trial for Lipedema focused on measuring Lipedema, complex decongestive therapy(CDT), liposuction
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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
Sites / Locations
- Praxis für Dermatologie, Dermatochirurgie und Phlebologie
- Venenzentrum Freiburg
- Universitätsklinikum Regensburg
- Klinikum Ernst von Bergmann
- Hautmedizin Bad Soden
- Hautklinik Darmstadt
- Hautarztpraxis Mühltal
- Evangelisches Krankenhaus Oldenburg Klinik für Plastische, Ästhetische, Rekonstruktive und Handchirurgie
- Johanniter GmbH Waldkrankenhaus Bonn
- Klinik und Praxisklinik für Plastische Chirurgie
- MVZ Praxis
- MVZ Praxis Dr. Cornely Düsseldorf MVZ Corius Nordrhein GmbH
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Other
Arm Label
Intervention group
Control group
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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).
Change in Health-Related Quality of Life According to SF-36 Questionnaire
Change in health-related quality of life according to SF-36 questionnaire.
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).
Change in Health-Related Quality of Life According to WHOQOL-BREF Questionnaire
Change in health-related quality of life according to WHOQOL-BREF questionnaire.
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).
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).
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).
Changed Prevalence of Edema
Changed prevalence of edema
Change in the Scope of the Physical Therapy
The scope of the physical therapy is measured by the number of treatment sessions per month.
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.
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).
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)
Number of Recurrent Interventions
Number of recurrent interventions
Number of (Serious) Adverse Events
Number of (serious) adverse events
Number of Therapy Interruptions Caused by Adverse Events
Discontinuation of therapy caused by adverse events
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.)
Full Information
NCT ID
NCT04272827
First Posted
February 12, 2020
Last Updated
October 19, 2023
Sponsor
Hautklinik Darmstadt
Collaborators
The Clinical Trials Centre Cologne
1. Study Identification
Unique Protocol Identification Number
NCT04272827
Brief Title
Evaluation Between Surgical Therapy of Lipedema Compared to Complex Physical Decongestive Therapy (CDT) Alone
Acronym
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)
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
December 15, 2020 (Actual)
Primary Completion Date
September 1, 2025 (Anticipated)
Study Completion Date
September 1, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hautklinik Darmstadt
Collaborators
The Clinical Trials Centre Cologne
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lipedema
Keywords
Lipedema, complex decongestive therapy(CDT), liposuction
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
After a run in phase, randomization is performed in the intervention and control arm (2:1).
Masking
Outcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
450 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Control group
Arm Type
Other
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Liposuction
Intervention Description
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.
Primary Outcome Measure Information:
Title
Successful Pain Reduction After 12 Months (≥ 2 Points on a Numeric Rating Scale)
Description
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.
Time Frame
12 months after completed liposuction treatment (intervention group) or after randomisation (control group) compared with the time of randomisation)
Secondary Outcome Measure Information:
Title
Change in Pain Severity as Assessed by German Pain Questionnaire
Description
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).
Time Frame
12 months after completed liposuction treatment (intervention group) or after randomization (control group) compared with the time of randomisation)
Title
Change in Health-Related Quality of Life According to SF-36 Questionnaire
Description
Change in health-related quality of life according to SF-36 questionnaire.
Time Frame
12 months after completed liposuction treatment (intervention group) or after randomization (control group) compared with the time of randomisation)
Title
Change in Health-Related Quality of Life According to DLQI Questionnaire
Description
Change in health-related quality of life according to DLQI questionnaire (a clinically relevant change corresponds to ≥ 4 points change in DLQI sum score).
Time Frame
12 months after completed liposuction treatment (intervention group) or after randomisation (control group) compared with the time of randomisation)
Title
Change in Health-Related Quality of Life According to WHOQOL-BREF Questionnaire
Description
Change in health-related quality of life according to WHOQOL-BREF questionnaire.
Time Frame
12 months after completed liposuction treatment (intervention group) or after randomisation (control group) compared with the time of randomisation)
Title
Change in Total Impairment According to Schmeller et al. (2010)
Description
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).
Time Frame
12 months after completed liposuction treatment (intervention group) or after randomisation (control group) compared with the time of randomisation)
Title
Altered Depression Tendency According to PHQ-9 Questionnaire
Description
Altered depression tendency according to PHQ-9 questionnaire (a clinically relevant improvement corresponds to ≥ 5 points reduction in PHQ-9 sum score).
Time Frame
12 months after completed liposuction treatment (intervention group) or after randomisation (control group) compared with the time of randomisation)
Title
Altered Hematoma Tendency According to Schmeller et al. (2010)
Description
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).
Time Frame
12 months after completed liposuction treatment (intervention group) or after randomisation (control group) compared with the time of randomisation)
Title
Changed Prevalence of Edema
Description
Changed prevalence of edema
Time Frame
12 months after completed liposuction treatment (intervention group) or after randomisation (control group) compared with the time of randomisation)
Title
Change in the Scope of the Physical Therapy
Description
The scope of the physical therapy is measured by the number of treatment sessions per month.
Time Frame
12 months after completed liposuction treatment (intervention group) or after randomisation (control group) compared with the time of randomisation)
Title
Change in Body Fat Percentage According to Wright et al. (1981)
Description
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.
Time Frame
12 months after completed liposuction treatment (intervention group) or after randomisation (control group) compared with the time of randomisation)
Title
Change of Leg Circumference by Means of Measuring Tape
Description
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).
Time Frame
12 months after completed liposuction treatment (intervention group) or after randomisation (control group) compared with the time of randomisation)
Title
Movement Restriction Reduction According to LEFS Sum Score
Description
Relevant reduction in movement restriction (stage I, II, or III; ≥ 9 points improvement in LEFS sum score)
Time Frame
12 months after completed liposuction treatment (intervention group) or after randomisation (control group) compared with the time of randomisation)
Title
Number of Recurrent Interventions
Description
Number of recurrent interventions
Time Frame
12 months after completed liposuction treatment (intervention group) or after randomisation (control group) compared with the time of randomisation)
Title
Number of (Serious) Adverse Events
Description
Number of (serious) adverse events
Time Frame
12 months after completed liposuction treatment (intervention group) or after randomisation (control group) compared with the time of randomisation)
Title
Number of Therapy Interruptions Caused by Adverse Events
Description
Discontinuation of therapy caused by adverse events
Time Frame
12 months after completed liposuction treatment (intervention group) or after randomisation (control group) compared with the time of randomisation)
Title
Optional: Change of the Leg Volume by Means of Perometry
Description
Optional: Change of the leg volume of the left and right leg (e.g. by means of perometry etc.)
Time Frame
12 months after completed liposuction treatment (intervention group) or after randomisation (control group) compared with the time of randomisation)
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
Lipedema is a symmetrical, congenital, excessive increase in fatty tissue on the legs, which occurs almost exclusively in women.
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maurizio Podda, Dr. med.
Organizational Affiliation
Hautklink Darmstadt
Official's Role
Study Chair
Facility Information:
Facility Name
Praxis für Dermatologie, Dermatochirurgie und Phlebologie
City
Freiburg
State/Province
Baden-Württemberg
ZIP/Postal Code
79098
Country
Germany
Facility Name
Venenzentrum Freiburg
City
Freiburg
State/Province
Baden-Württemberg
ZIP/Postal Code
79108
Country
Germany
Facility Name
Universitätsklinikum Regensburg
City
Regensburg
State/Province
Bavaria
ZIP/Postal Code
93053
Country
Germany
Facility Name
Klinikum Ernst von Bergmann
City
Potsdam
State/Province
Brandenburg
ZIP/Postal Code
14467
Country
Germany
Facility Name
Hautmedizin Bad Soden
City
Bad Soden am Taunus
State/Province
Hessen
ZIP/Postal Code
65812
Country
Germany
Facility Name
Hautklinik Darmstadt
City
Darmstadt
State/Province
Hessen
ZIP/Postal Code
64283
Country
Germany
Facility Name
Hautarztpraxis Mühltal
City
Mühltal
State/Province
Hessen
ZIP/Postal Code
64367
Country
Germany
Facility Name
Evangelisches Krankenhaus Oldenburg Klinik für Plastische, Ästhetische, Rekonstruktive und Handchirurgie
City
Oldenburg
State/Province
Lower Saxony
ZIP/Postal Code
26122
Country
Germany
Facility Name
Johanniter GmbH Waldkrankenhaus Bonn
City
Bonn
State/Province
North Rhine-Westphalia
ZIP/Postal Code
53177
Country
Germany
Facility Name
Klinik und Praxisklinik für Plastische Chirurgie
City
Cologne
State/Province
North Rhine-Westphalia
ZIP/Postal Code
50668
Country
Germany
Facility Name
MVZ Praxis
City
Cologne
State/Province
North Rhine-Westphalia
ZIP/Postal Code
51069
Country
Germany
Facility Name
MVZ Praxis Dr. Cornely Düsseldorf MVZ Corius Nordrhein GmbH
City
Düsseldorf
State/Province
NRW
ZIP/Postal Code
40474
Country
Germany
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
34717741
Citation
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.
Results Reference
derived
Learn more about this trial
Evaluation Between Surgical Therapy of Lipedema Compared to Complex Physical Decongestive Therapy (CDT) Alone
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