Intermittent ClaudicationFARONCT04376099
Focus on Analysis of Recovery in Oximetry
An observational study of Intermittent Claudication, run by University Hospital, Angers at 1 site in France.
Trial summary
Analysis of localizations for symptoms and ischemia on treadmill and of the recovery profiles of patients that have had an exercise oximetry Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intermittent Claudication
- What is being tested?
- Transcutaneous oxygen pressure measurement during the treadmill test
- How many people
- 1,000 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2018to 31 Dec 2019
- How long will I take part?
- 1 Day
- 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: Adult patients referred for exercise oximetry for intermittent claudication
Who may be able to join
- Available exercise oximetry recording
Who cannot join
- Deny of the use of the medical file from the patient
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Focus Sur l'Analyse de la récupération en oxymétries transcutanées (French Language)
Analysis of localizations for symptoms and ischemia on treadmill and of the recovery profiles of patients that have had an exercise oximetry
Read the detailed description
Patients referred for exercise oximetry have buttocks thighs and calves recording during exercise and in the recovery period for a minimum of 10 minutes.
For each limb probe the decrease from rest of oxygen pressure (DROP) index is calculated as a subtraction of chest changes from limb changes throughout rest, exercise and recovery. DROP was measured as a routine on buttocks, thighs and calves and a minimal DROP lower than minus 15 mmHg considered indicative of the presence of regional blood flow impairment (ischemia) in the considered area.
Recordings and patients characteristics are recorded on a institutionally validated database.
A comparison will be performed of symptoms by history to symptoms reported on treadmill and hemodynamic results attained through DROP values.
Re-analysis of the recordings after ethical approval will be performed in an aim at estimating the duration of 50% and 90% recovery of DROP at the different levels (buttocks tigh and calves) to account for hemodynamic impairmenty not only at the calf (calves) level.
- Conditions
- Intermittent Claudication
- Being tested
- Transcutaneous oxygen pressure measurement during the treadmill test
- Medical subject headings
- Intermittent Claudication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcutaneous oxygen pressure measurement during the treadmill testDiagnostic test
Calculation of the decrease from rest of oxygen pressure (DROP) throughout the period of rest exercise and recovery.
The DROP is calculated as chanegs on each limb probe minus changes on a chest reference probe from rest.
Analysis of the recovery period of the recordings will be done to seach for recovery 50% and 90% from the minimal DROP observed Evaluation of calf and non calf pain during the tests. Evaluation of calf and non calf (buttock or thigh) ischemia during the tests. Ischemia being defined as a monimal DROP lower than minus 15 mmHg.
| Study group | Role | What they receive |
|---|---|---|
| Exercise oximetry | Patients complaining claudication and referred for exercise diagnostic oximetry. Exercise oximetry are performed on treadmill (3.2km/h, 10% slope) Receives: Diagnostic Test: Transcutaneous oxygen pressure measurement during the treadmill test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Transcutanesous oximetry DROP index 50% recovery time
Time for the DROP index to reach 50% of its minimal value from the end of walking
Measured: Maximum 30 minutes (duration of the recovery phase)
Secondary outcomes (2)
Transcutanesous oximetry DROP index 90% recovery time
Time for the DROP index to reach 90% of its minimal value from the end of walking
Measured: Maximum 30 minutes (duration of the recovery phase)
Concordance of pain and ischemia during the treadmill test
Observation of calf and non calf pain and calf and non-calf ischemia in patients reporting calf pain by history. Ischemia being defined as a minimal DROP value lower than minus 15 mmHg.
Analysis of the concordance of localizations of pain and ischemia.
Measured: Maximum 60 minutes (duration of each test)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2020
- Study start1 Jan 2018
- Primary completion31 Dec 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intermittent 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 1,000 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Pierre ABRAHAM, MD; PhD, Principal investigator, UH in Angers (FRANCE)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04376099
- Sponsor's protocol ID
- 2020/42
- Acronym
- FARO
- Status last verified
- Apr 2020
- First submitted
- 28 Apr 2020
- Last updated
- 6 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Data available under reasonable request
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Focus Sur l'Analyse de la récupération en oxymétries transcutanées (French Language)
- ClinicalTrials.gov ID
- NCT04376099
- Acronym / sponsor ID
- FARO / 2020/42
- Conditions
- Intermittent Claudication
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- University Hospital, AngersOther government
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 6 May 2020 (actual)
- 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.
Analysis of localizations for symptoms and ischemia on treadmill and of the recovery profiles of patients that have had an exercise oximetry
Detailed description
Patients referred for exercise oximetry have buttocks thighs and calves recording during exercise and in the recovery period for a minimum of 10 minutes.
For each limb probe the decrease from rest of oxygen pressure (DROP) index is calculated as a subtraction of chest changes from limb changes throughout rest, exercise and recovery. DROP was measured as a routine on buttocks, thighs and calves and a minimal DROP lower than minus 15 mmHg considered indicative of the presence of regional blood flow impairment (ischemia) in the considered area.
Recordings and patients characteristics are recorded on a institutionally validated database.
A comparison will be performed of symptoms by history to symptoms reported on treadmill and hemodynamic results attained through DROP values.
Re-analysis of the recordings after ethical approval will be performed in an aim at estimating the duration of 50% and 90% recovery of DROP at the different levels (buttocks tigh and calves) to account for hemodynamic impairmenty not only at the calf (calves) level.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Exercise oximetry | – | Diagnostic Test: Transcutaneous oxygen pressure measurement during the treadmill testPatients complaining claudication and referred for exercise diagnostic oximetry. Exercise oximetry are performed on treadmill (3.2km/h, 10% slope) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients referred for exercise oximetry for intermittent claudication
Key inclusion criteria (1 listed)
- Available exercise oximetry recording
Key exclusion criteria (1 listed)
- Deny of the use of the medical file from the 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 |
|---|---|---|
| Transcutaneous oxygen pressure measurement during the treadmill testCalculation of the decrease from rest of oxygen pressure (DROP) throughout the period of rest exercise and recovery. The DROP is calculated as chanegs on each limb probe minus changes on a chest reference probe from rest. Analysis of the recovery period of the recordings will be done to seach for recovery 50% and 90% from the minimal DROP observed Evaluation of calf and non calf pain during the tests. Evaluation of calf and non calf (buttock or thigh) ischemia during the tests. Ischemia being defined as a monimal DROP lower than minus 15 mmHg. | Diagnostic test | Exercise oximetry |
Primary outcome
Transcutanesous oximetry DROP index 50% recovery time
Time frame: Maximum 30 minutes (duration of the recovery phase)
Time for the DROP index to reach 50% of its minimal value from the end of walking
2 secondary outcomes
Transcutanesous oximetry DROP index 90% recovery time
Time frame: Maximum 30 minutes (duration of the recovery phase)
Concordance of pain and ischemia during the treadmill test
Time frame: Maximum 60 minutes (duration of each test)
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 6 May 2020.
- Individual participant dataSharing planned: Undecided. Data available under reasonable request
Related trials for Intermittent 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.
Pierre ABRAHAM, MD; PhD principal investigator
UH in Angers (FRANCE)
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 Intermittent 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: finished, as of the sponsor's last update on 6 May 2020. 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?
Transcutanesous oximetry DROP index 50% recovery time (time frame: Maximum 30 minutes (duration of the recovery phase)). 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 6 May 2020.