E88.28
Conditions
Interventions
Group 1: All patients will be asked to wear compressions stockings over a period of 28 days for at least 6 days a weekk for at least 6 hrs per days. Via questionnaires the patient is requested to docu
Sponsors
eurocom e.V. (european manufacturers federation for compression therapy and orthopaedic devices)
Eligibility
Sex/Gender
Female
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: -written informed consent - female of at least 18 years of age - confirmed diagnosis of lipedema - no contraindication against flat-knitted compression garnment - expected good compliance in regards to wearing compression stockings ( at least 6 hours per day on at least 6 days a week) and study-related activties (study visits, completion of ePRO) - actual pain in the leg of at least 4.0 on the NRS at V0 daily access to smartphne, tablet or PC for using ePRO
Exclusion criteria
Exclusion criteria: - pregnant or breast feeding women - women of childbearing potential who intend to become pregnant during study conduct - isolated lipedema in the lower leg without participation of upper leg -diagnosis lymphedema, plebedema or myxedema - use of flat-knitted compression therapy for the management of the lipedema in the 4 weeks before study inclusion as well as in the time between inclusion and handover of test product -actual or planned therapy of the lipedema (including psychotherapy, manual lymph drainage, physio therapy etc) - planned liposuction within the next 3-6 months - already occured liposuction - patients who have requested disability pension benefit or plan to do so -any pain causing comorbidities, which will interfere with the pain symptomatic of the lipedema - advanced arterial occlusive disease defined as ABPI < 0,5, pressure in arteria of the ankle < 60 mmHg, toe pressure < 30 mmHg oder TcPO2 < 20 mmHg footback -decompensated heart insufficiency (NYHA III+IV) - septic superficial vein thrombosis (phlebitis) -phlegmasia coerula dolens - presence of one or several of following risks: intensive weeping dermatosis, intolerability to the compression material, severe sensibility disturbance of the extremity, advanced peripheral neuropathy (e.g. in diabetes mellitus), primary chronic polyarthritis - comorbidities which in the judgement of the investigator influences or interferes with the assessment of the study endpoint - alcohol- or drug abuse -regular pain treatment (e.g. medication) -particpation in another clinical study (actual or within the last 4 weeks) -study participation who are dependent on sponsor, manufacturer, CRO or site
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Absolute and percentage change of pain evaluation via numeric rating scale ((NRS), scale 1-10) during the study conduct | — |
Secondary
| Measure | Time frame |
|---|---|
| *Change of Intensitiy of pain (measured via NRS) in comparison to baseline at following timepoints: - 15 min afere first wearing of compression garnments at visit 1 - after at least 6 hours of wearing the compression garnments continously on days 1 to 27 at V2 *Change of quality of life in comprasion to baseline alue at visit 0, measured with - SF-36 on days 7, 14, 21, 28 Lymph-ICF-UG questionnaire (disturbance, limitiations and problem in participation, questionnaire für lymphedema of the lower extremities) on days 14 and 28, and -the WHO qulaity of life-abbreviated version of WHOQOL 10 (WHOQOL-BREF) on days 14 and28 *Change of the weekly average number of steps, measured via a fitness tracker, in comparison to baseline * tolerability | — |
Countries
Germany
Contacts
Public ContactTobias Hirsch
Praxis
Outcome results
None listed