Ankle Arterial Doppler Waveform Assessment For Surveillance Following Lower Limb Revascularisation (WAVE)

September 27, 2024 updated by: Imperial College London

The goal of this observational study is to determine the diagnostic performance of serial ankle arterial Doppler waveform assessments in detecting significant arterial restenosis in patients with Peripheral Arterial Disease (PAD) undergoing lower limb revascularization. The main questions it aims to answer are:

Can serial ankle Doppler waveform assessments accurately detect restenosis following revascularization? How cost-effective is this method for long-term patient surveillance? Researchers will compare the results of serial visual Doppler waveform assessments (handheld continuous-wave and pulsed-wave Doppler) with full lower limb arterial duplex ultrasound (DUS) to determine if the Doppler devices provide a comparable diagnostic performance.

Participants will:

Undergo regular pre- and post-revascularization ankle waveform assessments. Participate in follow-up surveillance visits at 3, 6, and 12 months.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

This study is a single-centre, prospective observational diagnostic accuracy study designed to evaluate the effectiveness of serial ankle arterial Doppler waveform assessments for post-revascularisation surveillance in patients with Peripheral Arterial Disease (PAD). The study will compare Doppler waveform assessments using both handheld continuous-wave Doppler and pulsed-wave duplex ultrasound (PWD) against a full lower limb duplex ultrasound (DUS), which serves as the reference standard.

Study Procedures:

The study involves a series of non-invasive, repeatable tests that monitor blood flow in the ankle arteries. The following arteries will be examined at the ankle:

Dorsalis pedis artery (DPA) Posterior tibial artery (PTA)

Waveforms are captured and analysed using both auditory and visual outputs from the Doppler devices. Pathological findings, such as monophasic waveforms (indicative of restenosis), will be compared to the normal biphasic or triphasic waveforms.

Index Tests:

Handheld Continuous-Wave Doppler (CWD):

A continuous signal captures real-time blood flow velocity. Visual and audio Doppler signals will be recorded, and waveform morphology will be assessed.

Waveforms will be stored on an external memory device for later analysis.

Pulsed-Wave Doppler (PWD) Duplex Ultrasound:

Provides detailed spectral waveform analysis of ankle vessels using a Doppler angle <60° to assess the velocity and shape of blood flow.

Key parameters such as peak systolic velocity (PSV) will be measured to detect stenosis.

Reference Test:

Full Lower Limb Arterial Duplex Ultrasound (DUS):

Conducted on all patients as part of routine care. Measures Peak Systolic Velocity (PSV) and PSV ratio at areas of suspected stenosis, covering the entire lower limb from the iliac to tibial arteries.

Data Collection:

Data will be collected during pre- and post-revascularisation procedures, and participants will undergo follow-up surveillance at 3, 6, and 12 months. The study will also assess the cost-effectiveness of using ankle Doppler assessments as a substitute for full lower limb DUS, with an evaluation of patient acceptability through Likert scale surveys.

Reliability Measures:

To ensure robustness, inter- and intra-rater reliability will be evaluated through repeated tests by the same and different operators. Machine learning algorithms will also be applied to classify arterial waveforms based on signal processing techniques.

Sample Size and Statistical Analysis:

The study will recruit 121 patients, with each participant undergoing three surveillance visits post-revascularisation. A total of 362 episodes or visits will be analysed. Sensitivity, specificity, and other diagnostic accuracy measures will be calculated, with Cohen's Kappa used to evaluate agreement between the index and reference tests.

The results of this study could provide a cost-effective, patient-friendly alternative for post-revascularisation surveillance, potentially reducing the need for full DUS exams while maintaining diagnostic accuracy.

Study Type

Observational

Enrollment (Estimated)

121

Contacts and Locations

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

Study Contact

Study Contact Backup

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

The study population will consist of adult patients with Peripheral Arterial Disease (PAD) undergoing lower limb revascularisation. The participants will be recruited from three hospitals and will include individuals from diverse demographic backgrounds, focusing on those eligible for surgical revascularisation. The study aims to include both male and female patients, with no restrictions based on race or ethnicity.

Description

Inclusion Criteria:

  • Adult patients (aged 18 and above) with diagnosed Peripheral Arterial Disease (PAD).
  • Patients scheduled for lower limb revascularisation procedures.
  • Patients willing and able to provide informed consent.
  • Patients who can attend follow-up visits at 3, 6, and 12 months post-revascularisation.

Exclusion Criteria:

  • Patients with non-compressible arteries (due to calcification or other reasons).
  • Patients who are unable to undergo Doppler assessments for any reason.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sensitivity of Ankle Doppler Waveform Assessment for Detecting Arterial Restenosis
Time Frame: 12 months post-revascularisation
The primary outcome is the diagnostic sensitivity of serial ankle Doppler waveform assessments (using continuous-wave and pulsed-wave Doppler) for detecting significant arterial restenosis in the dorsalis pedis artery and posterior tibial artery. The sensitivity of the Doppler waveform results will be compared against the reference standard of a full lower limb duplex ultrasound (DUS), performed at baseline and during follow-up surveillance visits post-revascularisation.
12 months post-revascularisation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Specificity and Predictive Values of Ankle Doppler Waveform for Arterial Restenosis
Time Frame: 12 months post-revascularisation
The secondary outcome measures include the specificity, positive predictive value (PPV), and negative predictive value (NPV) of serial ankle Doppler waveform assessments in detecting significant arterial restenosis in the dorsalis pedis and posterior tibial arteries. The Doppler waveform results will be compared against full lower limb duplex ultrasound (DUS) to assess the accuracy and clinical utility of this non-invasive method.
12 months post-revascularisation
Cost-Effectiveness of Ankle Doppler Waveform Assessment
Time Frame: 5 years
This secondary outcome measure evaluates the cost-effectiveness of using serial ankle Doppler waveform assessments compared to full lower limb duplex ultrasound (DUS) for post-revascularisation surveillance. Cost-related data, including the cost of equipment, personnel, and patient time, will be collected and analysed over a 5-year time horizon, alongside quality-adjusted life years (QALYs) and Incremental Cost-Effectiveness Ratios (ICER).
5 years

Collaborators and Investigators

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

Sponsor

Imperial College London

Investigators

  • Study Chair: Alun H Davies, Imperial College London

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 (Estimated)

October 10, 2024

Primary Completion (Estimated)

October 10, 2025

Study Completion (Estimated)

June 30, 2026

Study Registration Dates

First Submitted

September 20, 2024

First Submitted That Met QC Criteria

September 27, 2024

First Posted (Actual)

October 1, 2024

Study Record Updates

Last Update Posted (Actual)

October 1, 2024

Last Update Submitted That Met QC Criteria

September 27, 2024

Last Verified

September 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 24SM8819

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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