Functional Evaluation With Questionnaire in Patients Inve... | NCT01632033

Studies
Functional Evaluation With Questionnaire in Patients Investigated for Suspected Peripheral Artery Disease

NCT01632033

Sponsor

University Hospital, Angers

Status

Completed

Last Update Posted

Jul 17, 2015Estimated

Enrollment

150Actual

Phase

Not provided

Conditions

Peripheral Artery Disease

Interventions

Not provided

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2012

Primary Completion Date

Jul 2014Actual

Completion Date

Jul 2014Actual

First Submitted Date

Jun 28, 2012

First Submission Date that Met QC Criteria

Jun 28, 2012

First Posted Date

Jun 29, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 16, 2015

Last Update Posted Date

Jul 17, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

150Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Investigation for lower limb arteries		Patients referred for investigation of assumed peripheral artery disease (PAD)

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Scoring of the WELCH. Percent scored questionnaires	Predetermined scored . Scoring is optional and compared to scoring of the WIQ	1 day

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Sigjned consent for the data treatment as a database

Exclusion Criteria:

Non french native language age < 18 years old

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients referred for arterial leower limb investigations

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Denise JOLIVOT, MD	University Hospital, Angers	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospital		Angers			France

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
23663870	Derived	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.

ID	Term
D058729	Peripheral Arterial Disease
D007383	Intermittent Claudication

ID	Term
D050197	Atherosclerosis
D001161	Arteriosclerosis
D001157	Arterial Occlusive Diseases
D014652	Vascular Diseases