DUSTER

Full title: Duplex UltraSound afTer Endo Revascularisation – Feasibility Randomised Control Trial.

The DUSTER trial is a mixed methods study to evaluate the feasibility, acceptability and impact on clinical decision making of implementing an integrated ultrasound surveillance programme for patients after lower limb endovascular therapy.

It will be conducted in three phases: Phase I, a multi-site randomised controlled open label feasibility trial; Phase II, participant interviews; and Phase III, co-design of a large-scale trial.

Clouse-up of a pair of clinician's hands in blue rubber gloves squeezing jelly onto an ultrasound scanning device

In the UK, every year, 17,000 people develop foot pain or wounds from blocked leg arteries. If left untreated, this can lead to amputation.

Endovascular procedures are often used to open the blockages before they can cause serious problems. These include angioplasty (ballooning), stenting (leaving a tube inside the artery to keep it open) and other more complex procedures. These are successful in more than 90% of patients but, over two years, half will develop restenosis i.e. a re-narrowing of the arteries.

Vascular specialists currently identify restenosis through worsening pain, non-healing wounds or a lack of previously palpable foot pulses. Recognising the need to identify and treat restenosis, the 2019 European Society for Vascular Surgery guideline suggested three arterial lower limb ultrasound scans, with ankle brachial pressure index and toe pressure measurement, in addition to clinical follow up, to better identify restenosis within the first year.

DUSTER will assess the feasibility, acceptability and impact on clinical decision making of implementing a one-year integrated ultrasound surveillance programme for patients after lower limb endovascular therapy.

It will also lay the ground for a larger study of clinical and cost-effectiveness, by making sure that an ultrasound surveillance strategy is streamlined and acceptable for NHS adoption and by identifying potential outcome measures.

Trial setting, design, and methods

This is a multi-site study conducted at three NHS vascular units, involving Mid and South Essex NHS Foundation Trust, Imperial College Healthcare NHS Trust, and Manchester University NHS Trust.

It is a multi-site, randomised, controlled, open label, two-arm, feasibility trial.

The trial is recruiting 70 adults who have had successful lower limb endovascular therapy within last three weeks. They will be randomly allocated (1:1) to the trial intervention or comparison group over a 12-month period. Participants are randomised to either one-year integrated ultrasound plus clinical surveillance programme at 1, 6 and 12 months by a vascular specialist (intervention) or standard clinical surveillance programme at 1, 6 and 12 months by a vascular specialist (control).

Trial objectives

The primary objective is to assess the feasibility of implementing an integrated ultrasound surveillance programme for patients after lower limb endovascular therapy. Secondary objectives will also be assessed.



Chief Investigators: Dr Ankur Thapar (Mid and South Essex NHS Trust); Prof Alun Davies (Imperial College Healthcare NHS Trust)
ARCTU involvement: Trial management; database; randomisation service
Trial sponsor and funding: Mid and South Essex NHS Trust (sponsor); National Institute for Health Research (NIHR) Research for Patient Benefit programme (project reference RFPB207121) (funder); ARU and Mid and South Essex Vascular Unit (collaborators – see our vascular trials page for more information)
Project reference number: ClincialTrials.gov: NCT06702306