Evaluation Between Surgical Therapy of Lipedema Compared to Complex Physical Decongestive Therapy… (NCT04272827) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Evaluation Between Surgical Therapy of Lipedema Compared to Complex Physical Decongestive Therapy (CDT) Alone
Germany450 participantsStarted 2021-01-15
Plain-language 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).
Who can participate
Age range18 Years
SexFEMALE
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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).
What they're measuring
1
Successful Pain Reduction After 12 Months (≥ 2 Points on a Numeric Rating Scale)
Timeframe: 12 months after completed liposuction treatment (intervention group) or after randomisation (control group) compared with the time of randomisation)