Peripheral Artery DiseaseWELCH-bisNCT01632033
Functional Evaluation With Questionnaire in Patients Investigated for Suspected Peripheral Artery Disease
An observational study of Peripheral Artery Disease, run by University Hospital, Angers at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Artery Disease
- How many people
- 150 participants
- Where
- 1 siteFrance
- Study dates
- Jul 2012to Jul 2014
- Phase
- Observational
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Patients referred for arterial leower limb investigations
Who may be able to join
- Sigjned consent for the data treatment as a database
Who cannot join
- Non french native language age < 18 years old
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the detailed description
The WELCH and WIQ questionnaires are self completed by the patients and scored by the physician after self-completion.
- Conditions
- Peripheral Artery Disease
- Keywords
- Peripheral artery disease, claudication, walking, questionnaire
- Medical subject headings
- Peripheral Arterial Disease, Intermittent Claudication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Investigation for lower limb arteries | Patients referred for investigation of assumed peripheral artery disease (PAD) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Scoring of the WELCH. Percent scored questionnaires
Predetermined scored . Scoring is optional and compared to scoring of the WIQ
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2012 (estimated)
- Study startJul 2012
- Primary completionJul 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Peripheral Artery DiseaseStudies of the same condition, open and under way.
- More trials run by University Hospital, AngersThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Denise JOLIVOT, MD, Study chair, University Hospital, Angers
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01632033
- Sponsor's protocol ID
- PL 2012/14
- Acronym
- WELCH-bis
- Status last verified
- Jul 2015
- First submitted
- 28 Jun 2012
- Last updated
- 17 Jul 2015
- Results posted
- No
- Data monitoring committee
- Yes
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.
PubMed 23663870
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01632033
- Acronym / sponsor ID
- WELCH-bis / PL 2012/14
- Conditions
- Peripheral Artery Disease
- Keywords
- Peripheral artery disease, claudication, walking, questionnaire
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- University Hospital, AngersOther government
- Study start
- Jul 2012
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 29 Jun 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Investigation for lower limb arteries | – | –Patients referred for investigation of assumed peripheral artery disease (PAD) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients referred for arterial leower limb investigations
Key inclusion criteria (1 listed)
- Sigjned consent for the data treatment as a database
Key exclusion criteria (1 listed)
- Non french native language age < 18 years old
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Scoring of the WELCH. Percent scored questionnaires
Time frame: 1 day
Predetermined scored . Scoring is optional and compared to scoring of the WIQ
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2015.
- Derived from this study: PubMed 23663870Ouedraogo 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Denise JOLIVOT, MD study chair
University Hospital, Angers
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Peripheral Artery Disease, run by University Hospital, Angers at 1 site 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 17 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Scoring of the WELCH. Percent scored questionnaires (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 NCT01632033, which also lists 1 linked publication.
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 17 Jul 2015.