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Duplex ultrasound after endo revascularisation (DUSTER): protocol for a randomised controlled feasibility trial
Nishita Gadi1, Carmel Moore2, Karen Hayden2
1Mid and South Essex Vascular Unit, Mid and South Essex NHS Foundation Trust, Basildon, Essex, UK.
Insights
This study assesses a new ultrasound surveillance program for patients undergoing lower limb endovascular therapy. The DUSTER trial aims to improve restenosis detection and treatment, potentially reducing amputations.
Area of Science:
- Vascular Surgery
- Medical Imaging
- Health Services Research
Background:
- Endovascular therapy is primary for chronic limb ischaemia but has a high restenosis rate (50% over 2 years).
- Low reintervention rates post-therapy may lead to preventable amputations.
- European guidelines advocate ultrasound surveillance for early restenosis detection.
Purpose of the Study:
- To assess the feasibility and acceptability of a 1-year integrated ultrasound surveillance program (DUSTER) after lower limb endovascular therapy.
- To evaluate the impact of this surveillance on clinical decision-making.
- To explore patient and stakeholder perspectives on ultrasound surveillance.
Main Methods:
- A mixed-methods study including a three-site, feasibility, open-label, randomised controlled trial (Phase I).
- Intervention arm: integrated ultrasound (ABI, toe pressure, duplex) plus standard clinical surveillance.
- Control arm: standard clinical surveillance at 1, 6, and 12 months. Phase II: interviews; Phase III: focus groups.
Main Results:
- Primary outcomes: attendance/completion rates for ultrasound, reintervention rates for restenosis.
- Secondary outcomes: limb salvage, amputation-free survival, complications, mortality.
- Qualitative data will explore patient experiences and barriers/facilitators to surveillance.
Conclusions:
- The DUSTER study will provide crucial data on the feasibility and impact of integrated ultrasound surveillance.
- Findings will inform the potential implementation of enhanced surveillance protocols to improve outcomes for patients with chronic limb-threatening ischaemia.
- This research may help reduce amputation rates through earlier detection and treatment of restenosis.
Introduction:
Endovascular therapy is the main treatment for chronic limb-threatening ischaemia in the UK. Despite a restenosis risk of 50% over 2 years, reintervention rates are low, potentially resulting in preventable amputations. European guidelines recommend ultrasound surveillance to facilitate early treatment of restenosis. This study will investigate the use of duplex ultrasound after endo revascularisation (DUSTER). The aim is to assess the feasibility, acceptability and impact on clinical decision-making of a 1-year integrated ultrasound surveillance programme after lower limb endovascular therapy.
Methods And Analysis:
DUSTER is a mixed-methods study. Phase I is a three-site, feasibility, open-label, randomised controlled trial. The standard of care, the control arm, is standard clinical surveillance by a vascular specialist at 1, 6 and 12 months. The intervention arm will receive integrated ultrasound (ankle-brachial pressure index, toe pressure and duplex) plus standard clinical surveillance. Primary outcomes are rates of attendance and completion of ultrasound surveillance tests, as well as the percentage of participants undergoing reintervention for restenosis. Secondary outcomes are limb salvage, amputation-free survival, reasons for amputation, complications, serious adverse events and mortality.Phase II comprises independent semistructured interviews with intervention arm participants. The interviews will explore barriers and facilitators to ultrasound surveillance and the effect of ultrasound surveillance on patients' lives.Phase III has two separate focus groups for participants and clinical stakeholders to identify which outcomes matter most in any subsequent large-scale effectiveness trials.
Ethics And Dissemination:
This research has been approved by a UK (West Midlands, Black Country) Research Ethics Committee (reference 24/WM/0232) and the Health Research Authority (IRAS 349192). Dissemination of results will be by the DUSTER co-investigators in peer-reviewed journals, to the National Institute for Health and Care Research and to a lay audience via the Mid and South Essex NHS Foundations Trust website.
Trial Registration Number:
NCT06702306.
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