Ankle Arterial Doppler Waveform Assessment For Surveillance Following Lower Limb Revascularisation

NCT06619223 | Not Yet Recruiting DMC

• 1 other identifier: 24SM8819
• Study Type: observational
• Target: 121
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Peripheral Arterial Disease

Keywords

Peripheral Arterial Disease; Surveillance; ultrasound

Outcome Measures

Primary Outcomes (1)

• 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.

  12 months post-revascularisation

Secondary Outcomes (2)

• Specificity and Predictive Values of Ankle Doppler Waveform for Arterial Restenosis

  12 months post-revascularisation

• Cost-Effectiveness of Ankle Doppler Waveform Assessment

  5 years

Interventions

Duplex Ultrasound DIAGNOSTIC_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).

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Imperial College London: lead

Related Publications (1)

• 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.

  PMID: 41033760 DERIVED

MeSH Terms

Conditions

Peripheral Arterial Disease

Interventions

Ultrasonography, Doppler, Duplex

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Intervention Hierarchy (Ancestors)

Ultrasonography, Doppler; Ultrasonography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Alun H Davies

  Imperial College London

  STUDY CHAIR

Central Study Contacts

Hamidah Mabruk Alodayni

CONTACT

800-555-5555; h.alodayni23@imperial.ac.uk

Pasha Normahani

CONTACT

800-555-5555; p.normahani@imperial.ac.uk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 20, 2024
• First Posted: October 1, 2024
• Study Start: October 10, 2024
• Primary Completion: October 10, 2025
• Study Completion (Estimated): June 30, 2026
• Last Updated: October 1, 2024

Record last verified: 2024-09