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Clinical Trials/DRKS00031131
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.

Registry
who.int
Start Date
January 20, 2023
End Date
January 24, 2024
Last Updated
last year
Study Type
Observational
Sex
Female

Investigators

Sponsor
eurocom e.V. (european manufacturers federation for compression therapy and orthopaedic devices)

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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