Trial document




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  DRKS00000669

Trial Description

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Title

A prospective, randomised, controlled Study evaluating the effect of waterfiltered infrared A radiation (wIRA) on wound healing of venous leg ulcers

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

In this prospective, randomised, controlled Study the effect of waterfiltered infrared A radiation (wIRA) on wound healing of venous leg ulcers will be studied. Faster wound healing in the wIRA group is expected. Infrared a as part of the sunlight is known for 200 years. It is well tolerated by the skin, however a hydrocyvett filters parts that might burden the skin. As a result therapeutic infrared A application with very good skin tolerance and sufficient dosage in deeper layers can be achieved. The goal of the study is evaluation of the effects of wIRA on wound healing of venous leg ulcers

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Brief Summary in Scientific Language

This study will evaluate the efficiency of water filtered infrared A (wIRA) on wound healing in chronic venous leg ulcers. Further more this study will evaluate wound bed preparation and further parameters of the wounds during the therapy. 25 probands in the treatment group and 25 in the control group will be monitored over a 13 week period. Alltogether around 50 patients will be recruted for the study. In the treatment group the wIRA will be applied with a Hydrosun 505 irradiator with 185mW/cm2 irradiation and in the control group only visible light (VIS) will be emitted. The wIRA and VIS application will be performed over a 9 week period followed by a 4 week monitoring without light application. Both groups will receive stand moist wound therapy and compression therapy.

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Organizational Data

  •   DRKS00000669
  •   2011/05/18
  •   2006/07/10
  •   yes
  •   Approved
  •   85/06, Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
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Secondary IDs

  •   UKF000733  (Register klinischer Studien des Universitätsklinikums Freiburg)
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Health Condition or Problem studied

  •   I83.2 -  Varicose veins of lower extremities with both ulcer and inflammation
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Interventions/Observational Groups

  •   Treatment with water filtered infrared A (wIRA) plus standard therapy, with effective irradiation strength of 185mW/cm2 (visible light plus wIRA) and an effecitve infrared A amount of 140mW/cm2. wIRA will be applied 5 times per week, for 30 minutes vor maximum of 9 weeks or for 1 week longer than the time point of wound healing.
  •   Treatment with visual light without infrared plus standard therapy and standard therapy. In the control group the irradiation visual light with about 60mW/cm2 will be emitted. The treatment will be applied 5 times a week for 30 minutes for a maximum of 9 weeks or 1 week longer than the time point of wound healing.
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Blinded
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  •   Placebo
  •   Treatment
  •   Parallel
  •   N/A
  •   [---]*
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Primary Outcome

Wound closure or wound size reduction of a treatment intervall of maximum 13 weeks.

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Secondary Outcome

Change of wound exsudation, pain, granulation, coatings, epithelialization during therapy.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

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Recruitment

  •   Actual
  •   2006/07/17
  •   50
  •   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

patients over 18 years with
ulcers of the lower legs of predominantly venous genesis
(brachio-pedal index >0.6, wedge pressures >60 mm Hg);
chronic state (lasting more than 6 weeks with
no tendency to heal under the previous therapy);
ulcer size of 1–200 cm².

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Exclusion Criteria

vascular surgical or other vascular interventions in the area of the lower extremities within the last 6 weeks prior to inclusion in the study;
prior inclusion in this study; inclusion in an other study at the time of inclusion in this study;physical or mental illnesses (including severe accompanying basic illnesses, e.g. cancer, AIDS, severe anaemia, insufficiently treated diabetes mellitus) which do not allow participation in the treatment procedure of the study;
peripheral arterial occlusive disease (with clinical signs for a critical ischaemia, a brachio-pedal index <0.6 or a wedge pressure of the ankle or arch of the foot <60 mm Hg);
oral antibiotic treatment of the ulcer

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Addresses

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    • Universitäts-Hautklinik
    • Mr.  Dr.   Hauke  Schumann 
    • Haupstrasse 7
    • 79104  Freiburg
    • Germany
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    • Universitäts-Hautklinik
    • Mr.  Dr.   Hauke  Schumann 
    • Haupstrasse 7
    • 79104  Freiburg
    • Germany
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    • Universitäts-Hautklinik
    • Mr.  Dr.   Hauke  Schumann 
    • Haupstrasse 7
    • 79104  Freiburg
    • Germany
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Sources of Monetary or Material Support

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    • Dr. med. h.c. Erwin Braun Stiftung Advokatur und Notariat Dr. A. Gutmans
    • Aeschenvorstadt 55
    • CH-4010  Basel
    • Switzerland
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    •   +41 61 279 7000
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Status

  •   Recruiting complete, follow-up complete
  •   2008/10/01
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Trial Publications, Results and other Documents

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