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

Sponsored by Hautklinik Darmstadt

About this trial

Last updated 3 years ago

Study ID

LIPLEG-3806

Status

Active, not recruiting

Type

Interventional

Phase

N/A

Placebo

No

Accepting

18-75 Years
18+ Years
Female
Female

Not accepting

Not accepting
Healthy Volunteers

Trial Timing

Started 5 years ago

What is this trial about?

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).

What are the participation requirements?

Yes

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

No

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

Locations

Location

Status