Trial document




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  DRKS00000583

Trial Description

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Title

A prospective, monocentric clinical trial with adalimumab for topical treatment in chronic wounds

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Trial Acronym

ADATOP

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URL of the Trial

[---]*

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Brief Summary in Lay Language

Various therapeutic options were used in the former treatment of subjects without healing up. In ADATOP Adalimumab apply in area of the wound external only (so-called topic application). We hope that the clinical trial can improve wound healing, so wound closure could be possible.

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Brief Summary in Scientific Language

In this trial we will research the possible influence of wound healing by topic application of adalimumab weekly over maximal 8 weeks in chronic wounds without any other option of treatment.

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Organizational Data

  •   DRKS00000583
  •   2010/11/03
  •   [---]*
  •   yes
  •   Approved
  •   269-08, Ethikkommission an der Medizinischen Fakultät der Universität Leipzig
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Secondary IDs

  •   2009-015749-22 
  •   1183/01 
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Health Condition or Problem studied

  •   L97 -  Ulcer of lower limb, not elsewhere classified
  •   [---]* -  [---]*
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Interventions/Observational Groups

  •   topic application of adalimumab weekly over maximal 8 weeks
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Characteristics

  •   Interventional
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  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Treatment
  •   Single (group)
  •   II
  •   [---]*
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Primary Outcome

percental reduction of wound area under serial treatment with Adalimumab, measurement by fotographical documentation and measurement of the wound

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Secondary Outcome

- occurrence of new or aggravation of existent infection
- pain associated with chronic wound
- occurrence of possible contraindications

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • [---]*
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Recruitment

  •   Actual
  •   2011/08/12
  •   18
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

- at least one chronic wound without signs of infection. At the time point of study inclusion the wound must measure between 2,25 cm2 and 64 cm2.
- age ≥50 years
- at least 6 months existence without significant recovery although optimal wound care
- written informed consent

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Exclusion Criteria

- pregnancy and nursing women,
- presence of severe hepatic insufficiency or renal insufficiency
- presence of hepatitis
- chronic severe focus of infection
- severe wound infection
- known hypersensitivity to Adalimumab or other components of IMP
- signs of latent or active tuberculosis
- clinically decompensated heart failure (NYHA III/IV),
- inusfficient compliance
- active demyelinating or other neurological disorder
- malignant or lymphoproliferative disorder
- known autoimmune disorder
- intake of other immunodepressive drugs
- women of child bearing potential (< 2 years after last menstruation)
- concurrent participation in other clinical trials
- persons dependent on investigator

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Addresses

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    • Universität Leipzig
    • Ritterstraße 26
    • 04109  Leipzig
    • Germany
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    •   [---]*
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    • Universitätsklinikum Leipzig Klinik für Dermatologie, Venerologie und Allergologie
    • Mr.  Prof. Dr. med.  Jan Christoph  Simon 
    • Ph.-Rosenthal-Str. 23
    • 04103  Leipzig
    • Germany
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    • Universitätsklinikum Leipzig Klinik für Dermatologie, Venerologie und Allergologie
    • Mr.  Prof. Dr. med.  Jan Christoph  Simon 
    • Ph.-Rosenthal-Str. 23
    • 04103  Leipzig
    • Germany
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Sources of Monetary or Material Support

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    • Abbott Germany
    • Max-Planck-Ring 2a
    • 65205  Wiesbaden-Delkenheim
    • Germany
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    •   [---]*
    •   [---]*
    •   [---]*
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Status

  •   Recruiting stopped after recruiting started
  •   2012/06/29
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Trial Publications, Results and other Documents

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