Trial document




drksid header

  DRKS00017370

Trial Description

start of 1:1-Block title

Title

The influence of vascular surgery on gait parameters of patients suffering of peripheral arterial disease in stadium Fontaine 2b

end of 1:1-Block title
start of 1:1-Block acronym

Trial Acronym

[---]*

end of 1:1-Block acronym
start of 1:1-Block url

URL of the Trial

[---]*

end of 1:1-Block url
start of 1:1-Block public summary

Brief Summary in Lay Language

It is known that patients with peripheral arterial disease show reduced gait parameters compared to healthy individuals. Whereas little is known about the influence of vascular surgery on this parameters. The goal of this study is to analyze the influence with the help of a special treadmill system and conclude whether the surgery helps on the gait of patients or the aftercare has to be intensified.

end of 1:1-Block public summary
start of 1:1-Block scientific synopsis

Brief Summary in Scientific Language

Gait parameters of patients in intermittent claudication are analyzed before and after revascularisation surgery with help of Diers 4D motion lab to see if not only a painfree walk is possible but also gait parameters can be improved.
It was shown that gait parameters decrease in PAD and lead to falls etc.

end of 1:1-Block scientific synopsis
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00017370
  •   2019/07/05
  •   [---]*
  •   yes
  •   Approved
  •   473/18, Ethik-Kommission der Universität Ulm
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  • [---]*
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   I70.22 -  [generalization I70.2: Atherosclerosis of arteries of extremities]
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   revasculasation surgery on AFC oder AIE with pre and post surgical gait analysation on "Diers 4D motion lab"
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Interventional
  •   [---]*
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Prognosis
  •   Single (group)
  •   [---]*
  •   [---]*
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

No particular result ist searched for because this study is explorative. After surgery there will be a gait analyzation as soon as post surgical pain is no limiting factor in walking anymore. The analyzation is similar to presurgical measurement.
Pre and post surgical parameters will be compared afterwards

end of 1:1-Block primary endpoint
start of 1:1-Block secondary endpoint

Secondary Outcome

none

end of 1:1-Block secondary endpoint
start of 1:n-Block recruitment countries

Countries of Recruitment

  •   Germany
end of 1:n-Block recruitment countries
start of 1:n-Block recruitment locations

Locations of Recruitment

  • Medical Center 
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   Planned
  •   2019/07/10
  •   20
  •   Monocenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Both, male and female
  •   no minimum age
  •   no maximum age
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional Inclusion Criteria

signing of approval
peripheral arterial disease in lower extremities
indication for vascular surgery

end of 1:1-Block inclusion criteria add
start of 1:1-Block exclusion criteria

Exclusion Criteria

disease in motion and standing
disease of vestibular or nervous system
chronic heart failure NYHA >=3

end of 1:1-Block exclusion criteria
start of 1:n-Block addresses

Addresses

  • start of 1:1-Block address primary-sponsor
    • Bundeswehrkrankenhaus Ulm Abteilung für Unfallchirurgie & OrthopädieKlinischer Direktor: Prof. Dr. Friemert
    • Oberer Eselsberg 40
    • 89081  Ulm
    • Germany
    end of 1:1-Block address primary-sponsor
    start of 1:1-Block address contact primary-sponsor
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact primary-sponsor
  • start of 1:1-Block address scientific-contact
    • Bundeswehrkrankenhaus Ulm
    • Mr.  Dr.  Robert  Schmid 
    • Oberer Eselsberg 40
    • 89081  Ulm
    • Germany
    end of 1:1-Block address scientific-contact
    start of 1:1-Block address contact scientific-contact
    end of 1:1-Block address contact scientific-contact
  • start of 1:1-Block address public-contact
    • Bundeswehrkrankenhaus Ulm
    • Mr.  Moritz Alexander  Witzenhausen 
    • Oberer Eselsberg 40
    • 89081  Ulm
    • Germany
    end of 1:1-Block address public-contact
    start of 1:1-Block address contact public-contact
    end of 1:1-Block address contact public-contact
end of 1:n-Block addresses
start of 1:n-Block material support

Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Bundeswehrkrankenhaus UlmAbteilung für Unfallchirurgie und OrthopädieKlinischer Direktor: Prof. Dr. Friemert
    • Oberer Eselsberg 40
    • 89081  Ulm
    • Germany
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact materialSupport
end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Recruiting planned
  •   [---]*
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

  • [---]*
end of 1:n-Block publications
* This entry means the parameter is not applicable or has not been set.