DRKS00031131
Completed
Not Applicable
Evaluation of pain (Numeric Rating Scale (NRS) under flat knitted medical compression of the lower extremities in patients with lipedema (explorative study)
eurocom e.V. (european manufacturers federation for compression therapy and orthopaedic devices)0 sites24 target enrollmentJanuary 20, 2023
ConditionsE88.28
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- E88.28
- Sponsor
- eurocom e.V. (european manufacturers federation for compression therapy and orthopaedic devices)
- Enrollment
- 24
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
- •\- 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
Outcomes
Primary Outcomes
Not specified
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