Trial document




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  DRKS00012258

Trial Description

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Title

Influence of compression stockings on the skin hydration in patients with chronic venous insufficiency

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

Comparison of a normal compression stocking (Ccl II, AD) with a new compression stocking with an integrated care formula with respect to: skin hydration, skin roughness, the skin's moisture loss and effect on the leg girth (volume measurement of the legs) and wear comfort.
Patients between 18-80 years, which have a chronic venous disease, can be participants of the study.
With this study, we want to discuss if the compression stocking with integrated care formula has a positive effect on skin moisture, ckin roughness, comfort etc.) compared to a normal compression stocking.

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Brief Summary in Scientific Language

Comparison of a normal medical compression stocking (Ccl II, AD) with a new medical compression stocking with an integrated care formula with respect to: skin hydration, skin roughness, the transepidermal waterloss, the effect on changes of the leg volume and wear comfort.
Patients between 18-80 years, which have a chronic venous disease, can be participants of the study.
With this study, we want to discuss if the compression stocking with integrated care formula has a positive effect on skin moisture, ckin roughness, comfort etc.) compared to a normal compression stocking.

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Do you plan to share individual participant data with other researchers?

No

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Description IPD sharing plan:

[---]*

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Organizational Data

  •   DRKS00012258
  •   2017/04/20
  •   [---]*
  •   no
  •   Approved
  •   BB025/17, Ethikkommission an der Medizinischen Fakultät der Ernst-Moritz-Arndt-Universität Greifswald
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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
  •   chronic venous insufficiency
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Interventions/Observational Groups

  •   Patient group 1 (25 patients):
    Wearing of the normal compression stocking (Ccl II, AD) over a period of 28 days. The daily wearing time is 8 hours.
    During the carrying phase, the patients must fill out questionnaires every day.
  •   Patient group 2 (25 patients):
    Wearing of the compression stocking with integrated care formula (Ccl II, AD) over a period of 28 days. Daily wearing time by at least 8 h daily filling out questionnaires
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Active control (effective treament of control group)
  •   Treatment
  •   Parallel
  •   IV
  •   No
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Primary Outcome

Visit 1 (start of study) und Visit 28 (end of study after 28 days): measurement of skin hydration and measurement of the transepidermal water loss of the skin by means of Tewameter and Corneometer

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Secondary Outcome

Visit 1 (start of study) und Visit 28 (end of study after 28 days):
(1) measurement of the wear comfort with questionnaires
2)Skin roughness measurement by FOITS camera
3)PICO-press: fitting pressure between the compression stocking and skin
4)BT-600-measurement: measurement of volume of the legs

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2017/04/24
  •   50
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

(1) men and women between 18 and 80 years of age
(2) the subject consent
(3) Chronic Venous Insufficiency (Widmer St. I-IIIa, CEAP C1-5)
(4) subject is free of health problems (E.g. acute infections)
(5) subject is willing not to use any extra care products in the test area and use only a care-solids-free shower accessory provided by us

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Exclusion Criteria

(1) non-CVI related leg edema
(2) simultaneous participation in another study
(3) deep vein thrombosis
(4) arterial occlusive Disease
(5) active florides ulcer
(6) diabetes mellitus with neuropathy
(7) pregnancy
(8) inability to meet the criteria of the test plan
(9) the subject has known allergies to any of the ingredients of the test substance
(10) application of creams / care emulsions in the test area
(11) non-existent mobility

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Bauerfeind AG - Phlebology Business Development & Medical Affairs
    • Mr.  Dr.  Hans-Jürgen  Thomä 
    • Triebeserstraße 16
    • 07937  Zeulenroda
    • Germany
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    • Klinik und Poliklinik für Hautkrankheiten derUniversitätsmedizin Greifswald
    • Mr.  Prof. Dr. med.  Michael  Jünger 
    • Sauerbruchstraße
    • 17475  Greifswald
    • Germany
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    • Klinik und Poliklinik für Hautkrankheiten der Universitätsmedizin Greifswald
    • Ms.  Manuela  Reinhardt 
    • Sauerbruchstraße
    • 17475  Greifswald
    • Germany
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Sources of Monetary or Material Support

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    • Bauerfeind AG - Phlebology Business Development & Medical Affairs
    • Mr.  Dr.  Hans-Jürgen  Thomä 
    • Triebeserstraße 16
    • 07937  Zeulenroda
    • Germany
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Status

  •   Recruiting complete, follow-up complete
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  •   2017/08/11
  •   50
  •   50
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Trial Publications, Results and other Documents

  •   Westphal T, Konschake W, Haase H, Vollmer M, Jünger M, Riebe H. Medical compression stockings on the skin moisture in patients with chronic venous disease. VASA 2019;48(6):502-508. DOI: 10.1024/0301-1526/a000812.
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* This entry means the parameter is not applicable or has not been set.