Duplex ultrasound after endo revascularisation (DUSTER): protocol for a randomised controlled feasibility trial

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.