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

NCT06702306 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2025-12-30

No results posted yet for this study

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

Interventions

DIAGNOSTIC_TEST

Ultrasound Surveillance

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

Sponsors & Collaborators

  • Anglia Ruskin University

    collaborator OTHER

  • Imperial College Healthcare NHS Trust

    collaborator OTHER

  • Manchester University NHS Foundation Trust

    collaborator OTHER_GOV

  • Mid and South Essex NHS Foundation Trust

    lead OTHER

Principal Investigators

  • Ankur Thapar, PhD · Mid and South Essex NHS Foundation Trust

Study Design

Allocation
RANDOMIZED
Purpose
SCREENING
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-03-14
Primary Completion
2026-09-01
Completion
2026-12-01

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06702306 on ClinicalTrials.gov