Trial document




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  DRKS00005439

Trial Description

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Title

Failure to abbreviate non-invasive monofilament screening for diabetic peripheral neuropathies in children

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Trial Acronym

DPN-PP

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URL of the Trial

http://www.gerrithirschfeld.de/dpn/

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Brief Summary in Lay Language

Diabetic Polyneuropathies (DPN) are a major risk factor for developing severe complications. By usage of an intensified screening and a constitutive treatment, the amount of serious amputations in adults with diabetes mellitus can be reduced. In children the existence of DPN is detectable by nerve conduction studies too. In practice the same screening methodes (monofilaments, tuning-fork) are used in children and adolescents as on adults, though their utility is not approved. Based on the results of current studies it is thinkable, that a screening with finer monofilaments would reach a higher sensitivity and similiar well specifity like the previous methods. The goal of our study is to examine the finer monofilaments under clinical conditions.

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Brief Summary in Scientific Language

Examination of the diagnostical utility of two non-invasive screenings for diabetic peripheral neuropathies in clinical practice.

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Organizational Data

  •   DRKS00005439
  •   2013/11/18
  •   [---]*
  •   yes
  •   Approved
  •   65/2012, Ethik-Kommission der Universität Witten/Herdecke
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   E10.4 -  Insulin-dependent diabetes mellitus; With neurological complications
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Interventions/Observational Groups

  •   Monofilament (1mN, 2mN, 4mN) and tuning-fork screening (128hz)

    Patients will get examined consecutively by two different examiners, using the screening instruments described above. Final the interraterreliabilty of the results will get analyzed.
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Characteristics

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

sensitivity and specifity

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Secondary Outcome

interrater-reliabilty

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
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Recruitment

  •   Actual
  •   2013/12/02
  •   112
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   6   Years
  •   18   Years
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Additional Inclusion Criteria

diabetes mellitus E10.0 (ICD-10)

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Exclusion Criteria

known neurological disease, ulceration

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Addresses

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    • Vestische Caritas Kliniken GmbH
    • Mr.  Dr.   Gerrit   Hirschfeld 
    • Dr.-Friedrich-Steiner Str. 5
    • 45711  Datteln
    • Germany
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    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
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    • Vestische Kinder- und Jugendklinik Datteln
    • Mr.  Dr.  Gerrit  Hirschfeld 
    • Dr. Friedrich-Steiner Str. 5
    • 45711  Datteln
    • Germany
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    • Vestische Kinder- und Jugendklinik Datteln
    • Mr.  M.Sc. Psychologie  Michael  von Glischinski 
    • Hagemer Kirchweg 28
    • 45711  Datteln
    • Germany
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Sources of Monetary or Material Support

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    • Deutsche Forschungsgemeinschaft
    • Kennedyallee 40
    • 53175  Bonn
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2014/03/18
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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.