Peripheral Arterial Disease, Ankle Brachial Index, DopplerABIOSCILLONCT03511612
Comparison of the Ankle-Brachial Index Measurement Using a Specific Oscillometric Device vs. the Doppler Method
A study testing Measure ankle brachial index (ABI) in people with Peripheral Arterial Disease, Ankle Brachial Index, Doppler, run by University Hospital, Limoges at 1 site in France.
Trial summary
Several methods are available to measure ankle brachial index (ABI) non-invasively. A recent scientific statement of the AHA considers the Doppler method as the reference. However because Doppler devices are not widely available in primary care, several attempts have been made to propose alternative methods, among… Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Peripheral Arterial Disease, Ankle Brachial Index, Doppler
- What is being tested?
- Measure ankle brachial index (ABI)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteFrance
- Study dates
- 24 Apr 2018to 24 Oct 2018
- Phase
- Interventional
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients referred with the suspicion of PAD, either because of:
- symptoms in favor of intermittent claudication or more atypical pain when walking, or
- asymptomatic individuals with the presence of at least 2 cardiovascular risk factors among the following :
- Men > 60 years or women > 65 years
- Regular cigarette smoking >10 years, either current or in the past
- Treated Type-2 diabetes >5 years or Type-1 diabetes >20 years
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- Treated hypertension
- High blood cholesterol (either total-C >240 mg/dl or LDL-C >160 mg/dl) or treated by statins or other lipid-lowering agents
- Documented history of coronary artery disease (history of PCI or CABG, or previous myocardial infarction, or CAD documented by coronary angiography)
- Documented history of ischemic stroke
Who cannot join
- Patients with revascularized PAD
- Patients with critical limb ischemia or leg/foot ulcers
- Cardiac arrhythmia: Atrial fibrillation, atrial flutter, frequent supra- and ventricular ectopic beats
- Patients under dialysis
Trial locations and contacts
1 site in 1 country.
About this study
Several methods are available to measure ankle brachial index (ABI) non-invasively. A recent scientific statement of the AHA considers the Doppler method as the reference. However because Doppler devices are not widely available in primary care, several attempts have been made to propose alternative methods, among whom oscillometric methods (automatic blood pressure machines) have attracted most attention.
We hypothesize that:
- the diagnostic characteristics (i.e. sensitivity, specificity and AUC) of the oscillometric method would be very good as compared to the Doppler method. the oscillometric method would have better intra- and inter-observer reproducibilities as compared to the Doppler method.
- Being tested
- Measure ankle brachial index (ABI)
- 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.
Measure ankle brachial index (ABI)Diagnostic test
This is a head-to-head comparison of 2 methods of determination of the ABI, taking the Doppler method as the standard and the oscillometric device AVP as the challenger
| Study group | Role | What they receive |
|---|---|---|
| Pattern A | Other | Intervention : Each subject has 3 measurements of ABI starting with oscillometric device and then using the Doppler method. Receives: Diagnostic Test: Measure ankle brachial index (ABI) |
| Pattern B | Other | Intervention : Each subject has 3 measurements of ABI starting with Doppler method and then using oscillometric device. Receives: Diagnostic Test: Measure ankle brachial index (ABI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of the ABI
Measurement of the ABI, with Doppler method as reference
Measured: Day of the inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2018
- Study start24 Apr 2018
- Primary completion24 Oct 2018
- Study completion24 Oct 2018
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 Arterial Disease, Ankle Brachial Index, DopplerStudies of the same condition, open and under way.
- More trials run by University Hospital, LimogesThe 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Limoges
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03511612
- Sponsor's protocol ID
- 87RC17_0075 (ABIOSCILLO)
- Acronym
- ABIOSCILLO
- Status last verified
- Jul 2025
- First submitted
- 18 Apr 2018
- Last updated
- 1 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ichihashi S, Desormais I, Hashimoto T, Magne J, Kichikawa K, Aboyans V. Accuracy and Reliability of the Ankle Brachial Index Measurement Using a Multicuff Oscillometric Device Versus the Doppler Method. Eur J Vasc Endovasc Surg. 2020 Sep;60(3):462-468. doi: 10.1016/j.ejvs.2020.06.013. Epub 2020 Aug 3.
PubMed 32763120
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Ankle-Brachial Index Measurement Using a Specific Oscillometric Device vs. the Doppler Method
- ClinicalTrials.gov ID
- NCT03511612
- Acronym / sponsor ID
- ABIOSCILLO / 87RC17_0075 (ABIOSCILLO)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- University Hospital, LimogesUniversity, hospital or other
- Study start
- 24 Apr 2018 (actual)
- Primary completion
- 24 Oct 2018 (actual)
- Study completion
- 24 Oct 2018 (actual)
- First posted
- 30 Apr 2018 (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.
Several methods are available to measure ankle brachial index (ABI) non-invasively. A recent scientific statement of the AHA considers the Doppler method as the reference. However because Doppler devices are not widely available in primary care, several attempts have been made to propose alternative methods, among whom oscillometric methods (automatic blood pressure machines) have attracted most attention.
We hypothesize that:
- the diagnostic characteristics (i.e. sensitivity, specificity and AUC) of the oscillometric method would be very good as compared to the Doppler method. the oscillometric method would have better intra- and inter-observer reproducibilities as compared to the Doppler method.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pattern A | Other | Diagnostic Test: Measure ankle brachial index (ABI)Intervention : Each subject has 3 measurements of ABI starting with oscillometric device and then using the Doppler method. |
| Pattern B | Other | Diagnostic Test: Measure ankle brachial index (ABI)Intervention : Each subject has 3 measurements of ABI starting with Doppler method and then using oscillometric device. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- symptoms in favor of intermittent claudication or more atypical pain when walking, or
- asymptomatic individuals with the presence of at least 2 cardiovascular risk factors among the following :
Key exclusion criteria (4 listed)
- Patients with revascularized PAD
- Patients with critical limb ischemia or leg/foot ulcers
- Cardiac arrhythmia: Atrial fibrillation, atrial flutter, frequent supra- and ventricular ectopic beats
- Patients under dialysis
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 |
|---|---|---|
| Measure ankle brachial index (ABI)This is a head-to-head comparison of 2 methods of determination of the ABI, taking the Doppler method as the standard and the oscillometric device AVP as the challenger | Diagnostic test | Pattern A, Pattern B |
Primary outcome
Measurement of the ABI
Time frame: Day of the inclusion
Measurement of the ABI, with Doppler method as reference
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 1 Aug 2025.
- Results publication: PubMed 32763120Ichihashi S, Desormais I, Hashimoto T, Magne J, Kichikawa K, Aboyans V. Accuracy and Reliability of the Ankle Brachial Index Measurement Using a Multicuff Oscillometric Device Versus the Doppler Method. Eur J Vasc Endovasc Surg. 2020 Sep;60(3):462-468. doi: 10.1016/j.ejvs.2020.06.013. Epub 2020 Aug 3.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Measure ankle brachial index (ABI) in people with Peripheral Arterial Disease, Ankle Brachial Index, Doppler, run by University Hospital, Limoges 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 10 inclusion and 4 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 1 Aug 2025. 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?
Measurement of the ABI (time frame: Day of the inclusion). 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 NCT03511612, 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 1 Aug 2025.