ClaudicationPhase 1Initial-VHSNCT01022606
Intra-arterial Measurement of pO2 in Walking Induced Transient Hack Profiles
A Phase 1 study testing Arterial sampling in people with Claudication, run by University Hospital, Angers at 1 site in France.
Trial summary
Confirm with invasive measurement the presence of a Walking-Induced Transient Hack (WITH) profile Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Claudication
- What is being tested?
- Arterial sampling
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2009to Oct 2012
- Phase
- Phase 1
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- walking induced transient Hack (WITH) tcpO2 profile
Who cannot join
- rejection by patient
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Intra-arterial Measurement of pO2 in Walking Induced Transient Hack ("WITH") Profiles
Confirm with invasive measurement the presence of a Walking-Induced Transient Hack (WITH) profile
Read the detailed description
Arterial PO2 and body temperature measurements during exercise
- Conditions
- Claudication
- Being tested
- Arterial sampling
- Medical subject headings
- Intermittent Claudication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arterial samplingOther
Also called All material is CE marked and approved for huamn use
Arterial pO2 (ABL5) Body Temperature (Vitalsens Cortemp) tcpO2 TCM400
| Study group | Role | What they receive |
|---|---|---|
| Patients with walking limitation | Other | Patients with claudication and Walking-Induced Transient Hack (W.I.T.H.) tcpO2 profiles are tested on treadmill with invasive pO2 arterial sampling and body temperature recording Receives: Other: Arterial sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
arterial pO2
Measured: 2 months (time required to organise the test)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2009 (estimated)
- Study startOct 2009
- Primary completionOct 2012
- Study completionOct 2012
Why it stopped: Stopped for one complication event (arterial occlusion)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ClaudicationStudies 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
- Interventional
- Phase
- Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- P Abraham, MD, PhD, Study chair, University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01022606
- Sponsor's protocol ID
- PE 2009-16
- Acronym
- Initial-VHS
- Status last verified
- Mar 2013
- First submitted
- 24 Nov 2009
- Last updated
- 18 Mar 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intra-arterial Measurement of pO2 in Walking Induced Transient Hack ("WITH") Profiles
- ClinicalTrials.gov ID
- NCT01022606
- Acronym / sponsor ID
- Initial-VHS / PE 2009-16
- Conditions
- Claudication
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Stopped for one complication event (arterial occlusion)
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University Hospital, AngersOther government
- Study start
- Oct 2009
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 1 Dec 2009 (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.
Confirm with invasive measurement the presence of a Walking-Induced Transient Hack (WITH) profile
Detailed description
Arterial PO2 and body temperature measurements during exercise
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with walking limitation | Other | Other: Arterial samplingPatients with claudication and Walking-Induced Transient Hack (W.I.T.H.) tcpO2 profiles are tested on treadmill with invasive pO2 arterial sampling and body temperature recording |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- walking induced transient Hack (WITH) tcpO2 profile
Key exclusion criteria (1 listed)
- rejection by patient
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Arterial samplingAlso: All material is CE marked and approved for huamn useArterial pO2 (ABL5) Body Temperature (Vitalsens Cortemp) tcpO2 TCM400 | Other | Patients with walking limitation |
Primary outcome
arterial pO2
Time frame: 2 months (time required to organise the test)
Results and safety
The study was stopped early (reason given: Stopped for one complication event (arterial occlusion)). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2013.
Related trials for Claudication
Not yet recruiting
Daily Stretching to Improve Walking in Older Patients With Peripheral Artery Disease: The STRETCH PAD Study
Peripheral Artery Disease (PAD), Intermittent Claudication
Recruiting
EVERO Drug-coated Balloon (DCB) Randomized Trial
Peripheral Vascular Disease, Peripheral Arterial Disease
Recruiting
Personalised Multicomponent Exercise Programme in Peripheral Arterial Disease
Peripheral Arterial Disease, Intermittent Claudication
Active, not recruitingPhase 4
Ramipril Treatment of Claudication: Oxidative Damage and Muscle Fibrosis
Peripheral Arterial Disease
RecruitingPhase 3
Improving Mobility After Revascularization in Peripheral Artery Disease
Peripheral Artery Disease, Intermittent Claudication
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.
P Abraham, MD, PhD study chair
University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Arterial sampling in people with Claudication, 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: stopped early, as of the sponsor's last update on 18 Mar 2013. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Stopped for one complication event (arterial occlusion)). Results are not available in the source record.
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?
arterial pO2 (time frame: 2 months (time required to organise the test)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Mar 2013.