Trial document





This trial has been registered retrospectively.
drksid header

  DRKS00015116

Trial Description

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Title

Venous disease, vein symptoms, homeostatic feelings, gravitational stress test, compression therapy

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Trial Acronym

VSHF

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URL of the Trial

http://-

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Brief Summary in Lay Language

To test whether patients with venous disease of various degree of severity, when exposed to gravitational stress, experience leg volume increase and vein symptoms of different character and extent.

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Brief Summary in Scientific Language

(1) To test the influence of CEAP classification on a gravitational stress test with bare legs and when wearing compression stockings.
(2) To test whether the gravitational stress test can be used as a predictor for the usefulness of medical stockings in patient's everyday life.

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Organizational Data

  •   DRKS00015116
  •   2018/08/31
  •   [---]*
  •   no
  •   Approved
  •   39524/2015/47, Ethikkommission der Landesärztekammer Thüringen
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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
  •   CEAP classification: vein symptoms only (C0s, C1s), primary varicose veins (C2p), varicose veins plus edema (C2p&C3), venous dermatopathy (C4)
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Interventions/Observational Groups

  •   vein symptoms only (C0s, C1s)
  •   primary varicose veins (C2p)
  •   varicose veins plus edema (C2p&C3)
  •   venous dermatopathy (C4)
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Characteristics

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

The primary endpoint is the result of the gravitational stress test which assesses both the increase in the volume of the lower legs and the emergence of symptoms after 10 minutes standing still. The test is performed first with bare legs, then with medical compression stockings.

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Secondary Outcome

The secondary endpoint is the type of symptoms experienced during the week before and during the week after consultation compared with the symtoms in the stress test .

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Doctor's Practice 
  • Doctor's Practice 
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Recruitment

  •   Actual
  •   2015/05/26
  •   120
  •   Multicenter trial
  •   National
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Inclusion Criteria

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

Patients who fit the following criteria were included in the study: Patients with VS (vein symptoms) without clinical signs of venous disease or telangiectasia limited to the thigh (C0s, C1s), patients with varices, with or without VS (C2, C2s), patients with varices plus venous edema (C2 & C3), and patients with the dermatopathy of chronic venous insufficiency (C4).

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Exclusion Criteria

Exclusion criteria include if patients were younger than 18 or older than 75; if they weighed over 120 kilos; if they were pregnant; if an acute venous condition (phlebitis, deep venous thrombosis, dermatitis) existed or a healed or florid venous ulceration (C5, C6) was found; if any health condition that could interfere with the study endpoints existed (e.g. arteriopathy, neuropathy, lymphedema, arthropathy, medication used which included analgesics or antirheumatics); if compression bandages or stockings were used on the day of the consultation; if a patient was unable to change rapidly from the recumbent position to the standing position and to keep this position for 10 minutes during the stress test; if patients were unable or unwilling to wear compression stockings; or if patients were unable or unwilling to complete the questionnaires.

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Addresses

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    • Bauerfeind AG
    • Triebeser Str. 16
    • 07937  Zeulenroda
    • Germany
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    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
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    • Amsler Consulting
    • Mr.  MSc  Felix  Amsler 
    • Gundeldingerrain 111
    • 4059  Basel
    • Switzerland
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    end of 1:1-Block address contact scientific-contact
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    • Amsler Consulting
    • Mr.  MSc  Felix  Amsler 
    • Gundeldingerrain 111
    • 4059  Basel
    • Switzerland
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Sources of Monetary or Material Support

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    • Bauerfeind AG
    • Triebeser Str. 16
    • 07937   Zeulenroda-Triebes
    • Germany
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    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
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Status

  •   Recruiting complete, follow-up complete
  •   2018/07/13
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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.