Comparison of the Ankle-Brachial Index Measurement Using a Specific Oscillometric Device vs. the Doppler Method (ABIOSCILLO)

July 29, 2025 updated by: University Hospital, Limoges

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

51

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Limoges, France, 87200
        • University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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
    • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Pattern A
Intervention : Each subject has 3 measurements of ABI starting with oscillometric device and then using the Doppler method.
Diagnostic test: 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
Other: Pattern B
Intervention : Each subject has 3 measurements of ABI starting with Doppler method and then using oscillometric device.
Diagnostic test: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measurement of the ABI
Time Frame: Day of the inclusion
Measurement of the ABI, with Doppler method as reference
Day of the inclusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Limoges

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 24, 2018

Primary Completion (Actual)

October 24, 2018

Study Completion (Actual)

October 24, 2018

Study Registration Dates

First Submitted

April 18, 2018

First Submitted That Met QC Criteria

April 18, 2018

First Posted (Actual)

April 30, 2018

Study Record Updates

Last Update Posted (Actual)

August 1, 2025

Last Update Submitted That Met QC Criteria

July 29, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 87RC17_0075 (ABIOSCILLO)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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