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Functional Evaluation With Questionnaire in Patients Investigated for Suspected Peripheral Artery Disease (WELCH-bis)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01632033
Recruitment Status : Completed
First Posted : June 29, 2012
Last Update Posted : July 17, 2015
Sponsor:
Information provided by (Responsible Party):
University Hospital, Angers

Tracking Information
First Submitted Date June 28, 2012
First Posted Date June 29, 2012
Last Update Posted Date July 17, 2015
Study Start Date July 2012
Actual Primary Completion Date July 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 28, 2012)
Scoring of the WELCH. Percent scored questionnaires [ Time Frame: 1 day ]
Predetermined scored . Scoring is optional and compared to scoring of the WIQ
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT01632033 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Functional Evaluation With Questionnaire in Patients Investigated for Suspected Peripheral Artery Disease
Official Title Estimation de la capacité Fonctionnelle a la Marche Par Questionnaire Clinique Chez Des Patients adressés Pour Bilan artériel Des Membres inférieurs: Etude WELCH-bis
Brief Summary The purpose of this study is to test the routine faisibility of a questionnaire to estimate walking impairment(The WELCH questionnaire) in patients investigated for suspected PAD.
Detailed Description The WELCH and WIQ questionnaires are self completed by the patients and scored by the physician after self-completion.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients referred for arterial leower limb investigations
Condition Peripheral Artery Disease
Intervention Not Provided
Study Groups/Cohorts Investigation for lower limb arteries
Patients referred for investigation of assumed peripheral artery disease (PAD)
Publications * Ouedraogo N, Chanut M, Aubourg M, Le Hello C, Hidden V, Audat G, Harbonnier M, Abraham P. Development and evaluation of the Walking Estimated-Limitation Calculated by History questionnaire in patients with claudication. J Vasc Surg. 2013 Oct;58(4):981-8. doi: 10.1016/j.jvs.2013.03.039. Epub 2013 May 7.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: July 16, 2015)
150
Original Estimated Enrollment
 (submitted: June 28, 2012)
700
Actual Study Completion Date July 2014
Actual Primary Completion Date July 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Sigjned consent for the data treatment as a database

Exclusion Criteria:

  • Non french native language age < 18 years old
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT01632033
Other Study ID Numbers PL 2012/14
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party University Hospital, Angers
Study Sponsor University Hospital, Angers
Collaborators Not Provided
Investigators
Study Chair: Denise JOLIVOT, MD University Hospital, Angers
PRS Account University Hospital, Angers
Verification Date July 2015