Peripheral Arterial DiseaseWAVENCT06619223
Ankle Arterial Doppler Waveform Assessment For Surveillance Following Lower Limb Revascularisation
An observational study of Peripheral Arterial Disease, run by Imperial College London.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Arterial Disease
- What is being tested?
- Duplex Ultrasound
- How many people
- 121 participants
- Where
- No sites listed yet
- Study dates
- 10 Oct 2024to 30 Jun 2026
- 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: 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.
Who may be able to join
- 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.
Who cannot join
- Patients with non-compressible arteries (due to calcification or other reasons).
- Patients who are unable to undergo Doppler assessments for any reason.
Trial locations and contacts
No sites are listed yet.
About this study
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.
Read more
Participants will:
Undergo regular pre- and post-revascularization ankle waveform assessments. Participate in follow-up surveillance visits at 3, 6, and 12 months.
Read the 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.
- Conditions
- Peripheral Arterial Disease
- Being tested
- Duplex Ultrasound
- Keywords
- Peripheral Arterial Disease, Surveillance, ultrasound
- 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.
Duplex UltrasoundDiagnostic test
The primary intervention in this study is the use of ankle Doppler waveform assessment for post-revascularisation surveillance in patients with Peripheral Arterial Disease (PAD). This technique utilises continuous-wave Doppler (CWD) and pulsed-wave Doppler (PWD) to assess the blood flow in the key ankle arteries, including the dorsalis pedis artery (DPA) and posterior tibial artery (PTA).
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity of Ankle Doppler Waveform Assessment for Detecting Arterial Restenosis
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.
Measured: 12 months post-revascularisation
Secondary outcomes (2)
Specificity and Predictive Values of Ankle Doppler Waveform for Arterial Restenosis
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.
Measured: 12 months post-revascularisation
Cost-Effectiveness of Ankle Doppler Waveform Assessment
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).
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2024
- Study start10 Oct 2024 (estimated)
- Primary completion10 Oct 2025 (estimated)
- Study completion30 Jun 2026 (estimated)
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 DiseaseStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe 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
- Prospective
- Enrolment
- 121 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alun H Davies, Study chair, Imperial College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06619223
- Sponsor's protocol ID
- 24SM8819
- Acronym
- WAVE
- Status last verified
- Sep 2024
- First submitted
- 20 Sep 2024
- Last updated
- 1 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Alodayni HM, Smith S, Poushpas S, Swagell K, Mandic D, Johnson NA, Jaffer U, Davies A, Normahani P. Study protocol for a prospective diagnostic accuracy study to assess the feasibility and diagnostic accuracy of serial ankle handheld Doppler waveform assessment (Ankle HHD) for surveillance after lower-limb revascularisation: WAVE study. BMJ Open. 2025 Sep 30;15(9):e107609. doi: 10.1136/bmjopen-2025-107609.
PubMed 41033760
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ankle Arterial Doppler Waveform Assessment For Surveillance Following Lower Limb Revascularisation
- ClinicalTrials.gov ID
- NCT06619223
- Acronym / sponsor ID
- WAVE / 24SM8819
- Conditions
- Peripheral Arterial Disease
- Keywords
- Peripheral Arterial Disease, Surveillance, ultrasound
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 121 participants (estimated)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Study start
- 10 Oct 2024 (estimated)
- Primary completion
- 10 Oct 2025 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 1 Oct 2024 (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.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- Patients with non-compressible arteries (due to calcification or other reasons).
- Patients who are unable to undergo Doppler assessments for any reason.
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 |
|---|---|---|
| Duplex UltrasoundThe primary intervention in this study is the use of ankle Doppler waveform assessment for post-revascularisation surveillance in patients with Peripheral Arterial Disease (PAD). This technique utilises continuous-wave Doppler (CWD) and pulsed-wave Doppler (PWD) to assess the blood flow in the key ankle arteries, including the dorsalis pedis artery (DPA) and posterior tibial artery (PTA). | Diagnostic test | – |
Primary outcome
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.
2 secondary outcomes
Specificity and Predictive Values of Ankle Doppler Waveform for Arterial Restenosis
Time frame: 12 months post-revascularisation
Cost-Effectiveness of Ankle Doppler Waveform Assessment
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2024.
- Derived from this study: PubMed 41033760Alodayni HM, Smith S, Poushpas S, Swagell K, Mandic D, Johnson NA, Jaffer U, Davies A, Normahani P. Study protocol for a prospective diagnostic accuracy study to assess the feasibility and diagnostic accuracy of serial ankle handheld Doppler waveform assessment (Ankle HHD) for surveillance after lower-limb revascularisation: WAVE study. BMJ Open. 2025 Sep 30;15(9):e107609. doi: 10.1136/bmjopen-2025-107609.
- Individual participant dataSharing planned: Undecided
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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.
Alun H Davies study chair
Imperial College London
Questions about this trial
What is this clinical trial studying?
An observational study of Peripheral Arterial Disease, run by Imperial College London.
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 4 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 1 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hamidah Mabruk Alodayni (800-555-5555, h.alodayni23@imperial.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity of Ankle Doppler Waveform Assessment for Detecting Arterial Restenosis (time frame: 12 months post-revascularisation). 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 NCT06619223, 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 Oct 2024.