Duplex UltraSound afTer Endo Revascularisation - Feasibility Randomised Control Trial (DUSTER)

NCT06702306 | Active Not Recruiting

• 2 other identifiers: 349192RFPB207121
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

17, 000 people every year in the UK develop foot pain or wounds from blocked leg arteries. If left untreated, this can lead to amputation. Keyhole surgery is often used to balloon open the blockages before they can cause serious problems. However half of people over the next 2 years can develop further blockages, which can be identified by ultrasound scans of the leg arteries The aim of this clinical trial is to explore the benefits of regular ultrasound checks of the leg after keyhole surgery. In this study participants are randomly allocated to one of two groups. Half of participants will have standard clinic appointments with their vascular specialist at 1 month, 6 months and 12 months. The other half will have additional ultrasound scans of the leg arteries before their clinic appointments at 1, 6 and 12 months. We will then look at how many people attended the scans, whether the scans could be completed and how this affected decisions to have more surgery. At the end of the trial we will look at what happened to participants in both groups.

Conditions

Chronic Limb Threatening Ischaemia

Keywords

Chronic limb threatening ischaemia; endovascular; ultrasound surveillance; randomised controlled trial

Outcome Measures

Primary Outcomes (1)

• To assess feasibility of ultrasound surveillance

  * attendance at ultrasound surveillance appointments * completion rates of components of ultrasound surveillance * of participants undergoing arterial reintervention

  1 year

Secondary Outcomes (9)

• Limb Salvage

  1 year

• Quality of Life

  1 Year

• Disease specific quality of life

  1 Year

• Independence in daily activities

  1 Year

• Participant reported pain

  1 Year

Study Arms (2)

Control Group

NO INTERVENTION

At 1, 6 \& 12 months post-procedure, patient will have specialist clinic appointment, with the following: * Wound inspection, pedal pulse palpation * Questionnaires to assess quality of life \& pain (EQ5D-L, VASCUQOL-6, Barthel index, NRS-11)

Ultrasound Surveillance Group

EXPERIMENTAL

Will receive the same care as control group, plus, lower limb arterial ultrasound, ankle and toe blood pressure checks before every in-person clinic appointment at 1, 6 \& 12 months. Intervention arm participants are invited to take part in 1:1 interview with the research team after 6 months held as per participants' preference on MS Teams, via telephone, or in person.

Diagnostic Test: Ultrasound Surveillance

Interventions

Ultrasound Surveillance DIAGNOSTIC_TEST

Lower limb arterial ultrasound, ankle and toe blood pressure checks before every in-person clinic appointment at 1, 6 and 12 months.

Ultrasound Surveillance Group

Eligibility Criteria

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

You may qualify if:

• Adults (18y+) who have had successful lower limb endovascular therapy (angioplasty, stenting, atherectomy, lithotripsy, drug eluting balloon or stent, or combination of above) for chronic limb threatening ischaemia (ischaemic rest pain, ulceration or gangrene with arterial imaging confirming peripheral arterial disease). Technical success is defined as \<30% residual stenosis in the treated segments and patient leaving hospital without a major (above ankle) amputation on study leg
• Procedures within the last 3 weeks
• Interventions to iliac, femoral, tibial, and pedal vessels alone or in combination
• Endarterectomy or cutdown is permissible
• Able to give informed consent

You may not qualify if:

• Surgical bypass or endarterectomy alone undertaken
• Patient unfit for or does not want any future revascularisation
• Need for major amputation due to gas gangrene, severe Charcot deformity, extensive tissue loss with unstable foot, severe pedal disease on angiography or patient request
• Patient unwilling or cannot attend further surveillance
• Interventions for claudication or acute limb ischaemia or trauma
• Patients unable to take any form of antiplatelet therapy (aspirin or clopidogrel)
• Prior leg endovascular therapy at same anatomical location in study leg (within 1 year)
• Currently taking part in research that may impact on the results, design, or scientific value of this study or other studies that the potential participant may be taking part in.

Sponsors & Collaborators

• Anglia Ruskin University: collaborator
• Imperial College Healthcare NHS Trust: collaborator
• Manchester University NHS Foundation Trust: collaborator
• Mid and South Essex NHS Foundation Trust: lead

Study Sites (1)

Mid & South Essex NHS Foundation Trust

Basildon, Essex, SS16 5NL, United Kingdom

Location

Related Publications (1)

• Gadi N, Moore C, Hayden K, Zhang J, Beetar G, Rogers S, Smith-Ball C, Davies A, Thapar A. Duplex ultrasound after endo revascularisation (DUSTER): protocol for a randomised controlled feasibility trial. BMJ Open. 2025 Aug 10;15(8):e101137. doi: 10.1136/bmjopen-2025-101137.

  PMID: 40784780 DERIVED

MeSH Terms

Conditions

Chronic Limb-Threatening Ischemia

Condition Hierarchy (Ancestors)

Peripheral Arterial Disease; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Ischemia

Study Officials

• Ankur Thapar, PhD

  Mid and South Essex NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Feasibility Randomised Control Trial

Study Record Dates

• First Submitted: October 14, 2024
• First Posted: November 22, 2024
• Study Start: March 14, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: December 30, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Access Criteria: Ankur Thapar

Locations

GB (1)