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

Study Purpose

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).

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender Female
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04272827
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Hautklinik Darmstadt
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Maurizio Podda, Dr. med.
Principal Investigator Affiliation Hautklink Darmstadt
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Active, not recruiting
Countries Germany
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Lipedema
Additional Details

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.

Arms & Interventions

Arms

Active Comparator: 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.

Other: 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.

Interventions

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Freiburg, Baden-Württemberg, Germany

Status

Address

Praxis für Dermatologie, Dermatochirurgie und Phlebologie

Freiburg, Baden-Württemberg, 79098

Venenzentrum Freiburg, Freiburg, Baden-Württemberg, Germany

Status

Address

Venenzentrum Freiburg

Freiburg, Baden-Württemberg, 79108

Universitätsklinikum Regensburg, Regensburg, Bavaria, Germany

Status

Address

Universitätsklinikum Regensburg

Regensburg, Bavaria, 93053

Klinikum Ernst von Bergmann, Potsdam, Brandenburg, Germany

Status

Address

Klinikum Ernst von Bergmann

Potsdam, Brandenburg, 14467

Hautmedizin Bad Soden, Bad Soden am Taunus, Hessen, Germany

Status

Address

Hautmedizin Bad Soden

Bad Soden am Taunus, Hessen, 65812

Hautklinik Darmstadt, Darmstadt, Hessen, Germany

Status

Address

Hautklinik Darmstadt

Darmstadt, Hessen, 64283

Hautarztpraxis Mühltal, Mühltal, Hessen, Germany

Status

Address

Hautarztpraxis Mühltal

Mühltal, Hessen, 64367

Oldenburg, Lower Saxony, Germany

Status

Address

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

Oldenburg, Lower Saxony, 26122

Johanniter GmbH Waldkrankenhaus Bonn, Bonn, North Rhine-Westphalia, Germany

Status

Address

Johanniter GmbH Waldkrankenhaus Bonn

Bonn, North Rhine-Westphalia, 53177

Cologne, North Rhine-Westphalia, Germany

Status

Address

Klinik und Praxisklinik für Plastische Chirurgie

Cologne, North Rhine-Westphalia, 50668

MVZ Praxis, Cologne, North Rhine-Westphalia, Germany

Status

Address

MVZ Praxis

Cologne, North Rhine-Westphalia, 51069

Düsseldorf, NRW, Germany

Status

Address

MVZ Praxis Dr. Cornely Düsseldorf MVZ Corius Nordrhein GmbH

Düsseldorf, NRW, 40474

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The content provided in the Lipedema Foundation Legwork program is for informational purposes and does not, under any circumstance, constitute medical advice. Consult with your healthcare provider regarding any changes to your lipedema treatment including participation in any study. Information provided here is maintained by the TrialScope vendor and supplied by the individual study teams. Use of the TrialScope service requires acceptance of the TrialScope privacy policy and terms of service. Some features of the service may require registration of the user's contact information with TrialScope through the TrialScope website. Do not register if you do not consent to providing such information. The Lipedema Foundation does not guarantee that the contents are accurate or complete, or that any given study will be available for participation or applicable to your condition. The listing of a study on the site does not constitute an endorsement or recommendation of that study by the Lipedema Foundation. As such, you hereby waive claims and liability against the Lipedema Foundation for any harm, including bodily injury and death, that may result in connection with the use of this service. The Lipedema Foundation reserves the right, at its discretion, to omit studies or add studies to the service without notice. The Lipedema Foundation does not represent that the list of studies presented through the service is complete.

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