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Pilot Study to Determine the Optimal Technique for Measurement of Ankle Blood Pressures

Pilot Study to Determine the Optimal Oscillometric-Based Technique for Measurement of Ankle Blood Pressures for the Ankle-brachial Index

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00819598
Enrollment
70
Registered
2009-01-09
Start date
2009-01-31
Completion date
2009-10-31
Last updated
2009-11-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Peripheral Arterial Disease

Brief summary

Peripheral arterial disease (PAD) is a highly prevalent medical condition. Patients with PAD are usually diagnosed on the basis of the ankle-brachial index. The ankle-brachial index is the ratio of ankle pressure to arm pressure based on measurement of blood pressures in the arms and legs using a Doppler device. The need for dedicated equipment and trained personnel, along with the time required to perform the test, have been identified as barriers to widespread implementation of ankle-brachial index screening. The use of automated oscillometric devices for blood pressure measurement and determination of the ankle-brachial index has been applied with variable success. It will be beneficial to investigate a reliable oscillometric-based procedure that can accurately measure leg pressures for the ankle-brachial index across the entire spectrum of PAD severity. The purpose of this study is to determine the optimal oscillometric-based technique for estimation of Doppler-derived systolic arm and ankle blood pressures for calculation of the ankle-brachial index in patients with and without PAD. Subjects with suspected arterial disease in the non-invasive lab will be enrolled. Arm, ankle, and toe pressure measurements will be made in the supine position using Doppler, oscillometric methods, and photoplethysmographic sensor. Arm and ankle pressures from a subset of subjects will be obtained in both seated and supine positions. The ankle-brachial index and toe-brachial index will be calculated.

Interventions

PROCEDUREBLOOD PRESSURE MEASURMENT

Blood pressures using Doppler and oscillometric methods will be obtained at each limb and on one toe from each foot.

PROCEDUREBLOOD PRESSURE MEASUREMENT

Blood pressure measurements will be taken at each limb (arm and ankle) with Doppler and oscillometric based methods.

Sponsors

The Cleveland Clinic
CollaboratorOTHER
Summit Doppler Systems, Inc.
Lead SponsorINDUSTRY

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* Patient at least 50 years of age * Ambulatory outpatient * Referred to non-invasive Vascular Laboratory for evaluation of suspected arterial disease.

Exclusion criteria

* Unable to give informed consent * Unable to lie supine for at least 15 minutes

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026