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Peripheral Artery DiseasePhase 4WELCH-2NCT01424020

Walking Estimated Limitation Calculated by History - Study 2

A Phase 4 study testing Questionnaire in people with Peripheral Artery Disease, run by University Hospital, Angers at 18 sites in France.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The purpose of this study is to test and validate a new questionnaire in order to get a "walking estimated limitation calculated by history (WELCH) in patients referred for vascular investigations. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Peripheral Artery Disease
What is being tested?
Questionnaire
Could I receive a placebo?
No, everyone receives an active treatment
How many people
800 participants
Where
18 sitesFrance
Study dates
Sep 2011to Nov 2017
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • French Native language
  • 18 years old or older
  • Signed consent
  • Covered by the French social care system

Who cannot join

  • Unable to participate for administrative reasons
  • Psychiatric troubles
  • Pain at rest or critical limb ischemia
  • Unable to walk (ex: wheelchair subjects)
  • Note: previous inclusion in the protocole is note an exclusion criterion for a new participation.

Trial locations and contacts

18 sites in 1 country.

Pierre Abraham, MD; PhD contact

33 (0) 2 41 35 36 89

piabraham@chu-angers.fr

Johann Marchand, MD contact

welch@gernigon.fr

18 sites in 1 country

France18 sites, 17 recruiting

  • Vascular investigation

    Angers

    GEORGES LEFTHERIOTIS, MD

    MARIE-SOPHIE LEGRAND, MD

    Recruiting

  • Vascular Medicine

    Annecy

    Myriam MARTIN, MD

    Recruiting

  • Vascular Medicine

    Aubenas

    Myriam CHANUT, MD

    Recruiting

  • Rehabilitation

    Ballan-Miré

    Carine VOYER, MD

    Marion AUBOURG, MD

    Recruiting

  • Vascular Medicine

    Belfort

    Claude NICOL, MD

    Recruiting

  • Vascular Medicine

    Caen

    Claire LE HELLO, MD

    Recruiting

  • Vascular Medicine

    Castanet-Tolosan

    Joëlle LAFFONT, MD

    Recruiting

  • Vascular Medicine

    Champagnole

    Danielle BUFFARD, MD

    Recruiting

  • Vascular Medicine

    Chazelles-sur-Lyon

    Marjolaine BASSET-NEEL, MD

    Recruiting

  • Rehabilitation

    Hauteville

    Mario MAUFUS, MD

    Recruiting

  • Vascular Medicine

    Paris

    Aïssa SANOGO, MD

    Recruiting

  • Vascular Medicine

    Périgueux

    Claudette DELHOUME, MD

    Recruiting

  • Vascular Medicine

    Perpignan

    Maria DOAS, MD

    Recruiting

  • Vascular Medicine

    Reims

    Suspended

  • Vascular Medicine

    Sallanches

    Pierre-François GOY, MD

    Recruiting

  • Vascular Medicine

    Tarbes

    Catherine CLEDAT-WENDEL, MD

    Recruiting

  • Vascular Medicine

    Villenave-d'Ornon

    Sophie SKOPINSKI, Md

    Recruiting

  • Vascular Medicine

    Wattrelos

    Henic HIDDEN, MD

    Recruiting

Other trials in France

About this study

Official title: Estimation de la capacité Fonctionnelle à la Marche Par Questionnaire Clinique Chez Les Patients adressés Pour Bilan artériel Des Membres inférieurs

The purpose of this study is to test and validate a new questionnaire in order to get a "walking estimated limitation calculated by history (WELCH) in patients referred for vascular investigations.

Read the detailed description

Two questionnaires the WELCH and the "walking impairment questionnaire" (WIQ) are submitted to patients referred for vascular investigations for suspêcted peripheral arterial disease (PAD). Comparison of score to hemodynamic parameters (first goal) or maximal walking distance (MWD) on treadmill (secondary goal). Scoring of the WIQ is performed according to references. Scoring of the WELCH has been submitted for copyright protection (involves a series of 4 additions a subtraction and a single multiplication)

Being tested
Questionnaire
Keywords
Questionnaire, peripheral artery disease, execise
Medical subject headings
Peripheral Arterial Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • QuestionnaireOther

    Also called Walking impairment questionnaire (WIQ), Walking estimated limitation calculated by history (WELCH)

    Self completed questionnaire, Supervised by the physician Ankle brachial index (ABI) calculation Maximal walking distance (MWD) on treadmill or over the 6 minutes walking test (when available)

Study groups in NCT01424020
Study groupRoleWhat they receive
questionnaireExperimentalPatients suspected of peripheral artery disease and, as such, referred for a vascular investigations and submitted the WELCH questionnaire
Receives: Other: Questionnaire

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Proportion of questionnaires with errors after self completion

    Analysis of first inclusion only in patients that are included multiple times over the study period. Predetermined score for the WELCH questionnaire answers [(4 items); (4 additions \& 1 multiplication)] and WIQ... estimation of the percentage of errors with 95% confidence interval. Comparison of the two percentages

    Measured: 1 day

Secondary outcomes (5)

  1. Correlation with ankle brachial index (ABI)

    Analysis of first inclusion only in patients that are included multiple times over the study period. Calculation of questionnaire scores from predetermined methods and analysis of the coefficient of determination and coefficient of correlation to minimal ABI

    Measured: 1 day

  2. Correlation with treadmill result

    Analysis of first inclusion only in patients that are included multiple times over the study period.Calculation of questionnaires score from predetermined methods and analysis of the coefficient of determination and coefficient of correlation to maximal walking distance on treadmill, in the subgroup of patients that have a routine treadmill scheduled during the visit.

    Measured: 1 day

  3. Facility of the scoring of the questionnaires

    Proportion of WELCH scores calculated by physician and comparison to the proportion of WIQ score calculated by physicians as a estimation of the facility to calculate the score by mental calculation in routine

    Measured: 1 day

  4. Reliability of the questionnaire

    Comparison of the scores of the WELCH in the patients that may be seens within 3 weeks of their first inclusion, for any reasons, (e.i. seen first for a doppler and two weeks later for a treadmill test)over the study period. Analysis of the reliability through the coefficient of variation of the score.

    Measured: 3 weeks

  5. sensitivity of the WELCH to changes

    Comparison of the scores of the WELCH in the patients that may be seens within 1 year from their first inclusion, for any reasons, (e.i. seen follow up of their disease)over the study period. Analysis of the changes of the score to changes of the ABI. Analysis of the changes of the score to changes in maximal walking distance if available.

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Aug 2011 (estimated)
  2. Study startSep 2011
  3. Primary completionNov 2017 (estimated)
  4. Study completionNov 2017 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Diagnosis
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
800 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01424020
Sponsor's protocol ID
CHU-P 2011-06
Acronym
WELCH-2
Status last verified
Dec 2016
First submitted
23 Aug 2011
Last updated
19 Dec 2016
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Questionnaire in people with Peripheral Artery Disease, run by University Hospital, Angers at 18 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 19 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 18 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Pierre Abraham, MD; PhD (33 (0) 2 41 35 36 89, piabraham@chu-angers.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of questionnaires with errors after self completion (time frame: 1 day). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01424020.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2016.

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