Trial document




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  DRKS00013886

Trial Description

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Title

Prospective, controlled pilot study for the use of non-contact perfusion and thermography measurements in patients with peripheral arterial disease, chronic venous insufficiency, or diabetes mellitus (with or without ulceration) compared to patients with spider vein varikosis

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Trial Acronym

[---]*

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URL of the Trial

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Brief Summary in Lay Language

Non-contact perfusion and thermography measurements in patients with peripheral arterial occlusive disease, chronic venous insufficiency or diabetes mellitus (with or without ulceration) compared to patients with spider vein varikosis

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Brief Summary in Scientific Language

Additional possibility to be able to estimate the severity of the venous and arterial perfusion disturbance on the basis of the non-contact observed camera parameters.

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Organizational Data

  •   DRKS00013886
  •   2018/01/30
  •   [---]*
  •   yes
  •   Approved
  •   17-6146, Ethik-Kommission der Medizinischen Fakultät der Ruhr-Universität Bochum
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Secondary IDs

  •   VZ-2018-01  (interne Prüfnummer)
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Health Condition or Problem studied

  •   Circulatory disorders in venous disease, arterial occlusive disease and diabetes mellitus in cf. to spider veins varicosis
  •   I87 -  Other disorders of veins
  •   I70.2 -  Atherosclerosis of arteries of extremities
  •   E13 -  Other specified diabetes mellitus
  •   I83.9 -  Varicose veins of lower extremities without ulcer or inflammation
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Interventions/Observational Groups

  •   Non-contact perfusion and thermography measurements with Digital camera, Thermographiekamera, infrared camera, recording with Hyperspektralkamera in patients with peripheral arterial occlusive disease
  •   Non-contact perfusion and thermography measurements with Digital camera, Thermographiekamera, infrared camera, recording with Hyperspektralkamera in patients with chronic venous insufficiency
  •   Non-contact perfusion and thermography measurements with Digital camera, Thermographiekamera, infrared camera, recording with Hyperspektralkamera in patients with diabetes mellitus (with or without ulceration)
  •   Non-contact perfusion and thermography measurements for comparision in patients with Spider vein varicosis.
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Characteristics

  •   Non-interventional
  •   Other
  •   Non-randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Other
  •   Other
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

The target parameters are the non-contact perfusion and thermography measurements at the time of the conclusion visit.
Measured with:
Infrared thermography: target parameters:
1. Spatially resolved measurement of the temperature in the wound region.
2. Shape and size of the wound.

Near-infrared (PPGI): Target parameters:
1. Quantification of perfusion in the wound region.

Canon camera: target parameters:
1.Shape, size and color of the wound.

Hyperspectral camera: target parameters:
2. Quantification of wound region and environment perfusion by calculation of tissue oxygenation, near-infrared perfusion index, tissue hemoglobin index and tissue-water index of human tissue

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Secondary Outcome

/

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
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Recruitment

  •   Planned
  •   2018/02/16
  •   40
  •   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

•Men and women
• Age> 18 years
• written consent
• Possibility and will to participate
• Known vascular disease of the legs in defined stages (CVI C3-C6 or PAD
IIb-IV or diabetes mellitus with / without ulceration) or healthy leg vessels (spider veins / ret. Varices only)
• No surgical or interventional treatment of the legs / leg vessels in the last 6 months

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Exclusion Criteria

• Lack of consent
• Lack of will or lack of opportunity to follow the examination protocol
• Acute thrombosis of the arterial or venous leg vessels
• Acute inflammation of the legs
• Extensive scars on the legs after trauma
• immobilization
• Pregnancy, breastfeeding
• Skin type IV to VI

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Addresses

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    • Phlebologisches Studienzentrum am Venenzentrum der Dermatologischen und Gefäßchirurgischen Kliniken
    • Ms.  Prof. Dr.  Stefanie  Reich-Schupke 
    • Hiltroper Landwehr 11-13
    • 44805  Bochum
    • Germany
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    • Lehrstuhl für Medizinische Informationstechnik an der Fachhochschule Aachen
    • Mr.  Prof. Dr. Ing.  Steffen  Leonhardt 
    • Pauwelsstr. 20
    • 52074  Aachen
    • Germany
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    • Phlebologisches Studienzentrum am Venenzentrum der Dermatologischen und Gefäßchirurgischen Kliniken
    • Ms.  Prof. Dr.  Stefanie  Reich-Schupke 
    • Hiltroper Landwehr 11-13
    • 44805  Bochum
    • Germany
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    • Phlebologisches Studienzentrum am Venenzentrum der Dermatologischen und Gefäßchirurgischen Kliniken
    • Ms.  Prof. Dr.  Stefanie  Reich-Schupke 
    • Hiltroper Landwehr 11-13
    • 44805  Bochum
    • Germany
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Sources of Monetary or Material Support

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    • Phlebologisches Studienzentrum am Venenzentrum der Dermatologischen und Gefäßchirurgischen Kliniken
    • Ms.  Prof. Dr.  Stefanie  Reich-Schupke 
    • Hiltroper Landwehr 11-13
    • 44805  Bochum
    • Germany
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Status

  •   Recruiting planned
  •   [---]*
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Trial Publications, Results and other Documents

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