Trial document




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  DRKS00013029

Trial Description

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Title

Prospective, open study on morphology and symptoms of untreated teleangiectasias

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Trial Acronym

[---]*

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URL of the Trial

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Brief Summary in Lay Language

Aim of the study will be, to gain awareness of the morphology and symptomatic of teleangiectasias and to find answers of the following questions:
*which types of teleangiectasias are relevant in matters of site, morphology and symptoms?
* are there differences in morphology and symptoms according to hemodynamic relevant vein diseases?
* are there differences according to gender, weight or mobility?

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Brief Summary in Scientific Language

Background: almost everyone suffers from teleangiectases sooner or later in his life. The first appearance of teleangiectases is already witnessed during childhood or early adulthood. But type and shape are individually very different. Some pat. don't suffer at all and others complain about paraesthesia. It seems that there are different types of teleangiectases, that appear in addition to a hemodynamic vein disease.
Until now there are no researches about teleangiectases and against this background there will be a research about the morphology and symptoms of untreated teleangiectases.
Aim is to gain awareness of morphology and symptoms of teleangiectases and to find answers to the following questions: are there interrelations between gender, weight and mobility?
The design of the research will be open, non-interventional and prospective.

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Organizational Data

  •   DRKS00013029
  •   2017/09/14
  •   [---]*
  •   yes
  •   Approved
  •   17-6093, Ethik-Kommission der Medizinischen Fakultät der Ruhr-Universität Bochum
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Secondary IDs

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Health Condition or Problem studied

  •   I83.9 -  Varicose veins of lower extremities without ulcer or inflammation
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Interventions/Observational Groups

  •   Pat. with untreated teleangiectasias are inspected one-time and asked for symptoms, measured by means of a questionnaire. In case of eye-catching diagnostic findings, there will be a documentation in pictures.
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Characteristics

  •   Non-interventional
  •   Other
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Diagnostic
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

Type of teleangiectasias

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Secondary Outcome

gender, Body-Mass-Index, mobility (questionnaire), clinical relevant paod (peripheral arterial
occlusive disease), clinical relevant vein disease, pain of the legs (visual analogue scale), itching of the legs ((visual analogue scale)

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2017/09/18
  •   200
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

*Patient of the vein centre
* signed Agreement
* until now no Treatment of vein deseases (exception: occasional wear of medical compression stockings)
* all clinical states of varicosis C1-C6

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Exclusion Criteria

* missing verbal skills or missing comprehension to fill in the form
* neurological diseases that reduce the sensitivity of the legs (paraplegia, advanced neuropathy)

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Addresses

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Sources of Monetary or Material Support

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Status

  •   Recruiting complete, follow-up complete
  •   2018/05/22
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.