Chronic Limb Threatening IschaemiaDUSTERNCT06702306
Duplex UltraSound afTer Endo Revascularisation - Feasibility Randomised Control Trial (DUSTER)
A study testing Ultrasound Surveillance in people with Chronic Limb Threatening Ischaemia, run by Mid and South Essex NHS Foundation Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Limb Threatening Ischaemia
- What is being tested?
- Ultrasound Surveillance
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 14 Mar 2025to 1 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Mid & South Essex NHS Foundation Trust
Basildon, Essex, SS16 5NL
About this study
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.
Read more
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.
Read the detailed description
Phase 1: Feasibility RCT
The study is a multi-site, randomised (1:1), controlled, open label, 2 arm, feasibility trial.
DUSTER will be performed in 3 NHS vascular units at the following NHS Trusts:
- Mid and South Essex NHS Foundation Trust
- Imperial College Healthcare NHS Trust
- Manchester University NHS Trust
These sites comprise two urban and one rural site, in both the North, South and East of the country. This will help understand the effects of travel, ethnicity, and geography on attending appointments. Following NIHR INCLUDE guidance we have costed for translation of study materials / interpreters.
Phase 2: Participant interviews
Participants in the intervention arm will be invited to individual semi-structured interviews with members of the research team. The interviews will be held as per participants' preference on MS Teams, or via telephone, or in person, after a minimum 6 month follow up.
The interviews seek to explore factors affecting adherence and the impact of integrated surveillance on patients. It will apply a Qualitative Descriptive Research (QDR) approach and aims to inquire into the experience of everyday living with chronic limb threatening ischaemia. QDR aims to provide broad insight into phenomena as experienced/lived by individuals and is widely used as the qualitative component in mixed-methodology studies especially in large-scale healthcare intervention studies to identify participants' perceptions of why ultrasound surveillance worked or did not work and how it might be better implemented. Using QDR in this manner can make modifications to how surveillance is delivered in a future HTA study, including behavioural modifications such as educational tools, automated reminders along with intervention modifications e.g. community-based scanning.
Phase 3: Participant and stakeholder focus groups
After the feasibility study, we will invite participants and stakeholders to 2 separate focus groups (face to face or MS teams-hybrid) to discuss potential secondary endpoints for a future HTA application (e.g. amputation free survival, quality of life and cost-effectiveness). These will be co-chaired with our lay co-applicants.
HTA application drafting
If progression criteria are met (see , Phases 1 -3 will feed into a draft HTA application in the final month of the study. The progression criteria are:
- >80% of ultrasound surveillance appointments are attended (>72/90), AND
- >90% completion rate of at least one ultrasound scan component (>81/90), AND
- There is an increase of >10% in re-interventions in ultrasound surveillance arm (>3 patients).
- Conditions
- Chronic Limb Threatening Ischaemia
- Being tested
- Ultrasound Surveillance
- Keywords
- Chronic limb threatening ischaemia, endovascular, ultrasound surveillance, randomised controlled trial
- Medical subject headings
- Chronic Limb-Threatening Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound SurveillanceDiagnostic test
Lower limb arterial ultrasound, ankle and toe blood pressure checks before every in-person clinic appointment at 1, 6 and 12 months.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Ultrasound Surveillance |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess feasibility of ultrasound surveillance
- attendance at ultrasound surveillance appointments
- completion rates of components of ultrasound surveillance
- of participants undergoing arterial reintervention
Measured: 1 year
Secondary outcomes (9)
Limb Salvage
Limb salvage
Measured: 1 year
Quality of Life
Quality of Life measured via EQ5D-L questionnaire
Measured: 1 Year
Disease specific quality of life
Disease specific quality of life measured via VASCUQOL-6 questionnaire
Measured: 1 Year
Independence in daily activities
Independence in activities of daily living measured via the Barthel index
Measured: 1 Year
Participant reported pain
Pain scores measured via NRS-11 questionnaire
Measured: 1 Year
Amputations
Number and reasons for major amputation
Measured: 1 Year
Serious reintervention complications
Serious reintervention complications (Clavien-Dindo Grade III-V)
Measured: 1 Year
Adverse events (cardiac/cerebrovascular)
Major adverse cardiac or cerebrovascular events
Measured: 1 Year
Mortality
Mortality and cause of death
Measured: 1 Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2024
- Study start14 Mar 2025
- Primary completion1 Sep 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Limb Threatening IschaemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Feasibility Randomised Control Trial
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mid and South Essex NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Anglia Ruskin University, Imperial College Healthcare NHS Trust, Manchester University NHS Foundation Trust
- Responsible party
- Sponsor
- Investigators
- Ankur Thapar, PhD, Principal investigator, Mid and South Essex NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06702306
- Sponsor's protocol ID
- 349192
- Other IDs
- RFPB207121
- Acronym
- DUSTER
- Status last verified
- Jul 2025
- First submitted
- 14 Oct 2024
- Last updated
- 30 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymised outcome data for primary and secondary endpoints to 12 months will be made available for IPD meta-analysis.
Publications
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.
PubMed 40784780
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Duplex UltraSound afTer Endo Revascularisation - Feasibility Randomised Control Trial (DUSTER)
- ClinicalTrials.gov ID
- NCT06702306
- Acronym / sponsor ID
- DUSTER / 349192
- Conditions
- Chronic Limb Threatening Ischaemia
- Keywords
- Chronic limb threatening ischaemia, endovascular, ultrasound surveillance, randomised controlled trial
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Mid and South Essex NHS Foundation TrustUniversity, hospital or other
- Collaborators
- Anglia Ruskin University, Imperial College Healthcare NHS Trust, Manchester University NHS Foundation Trust
- Study start
- 14 Mar 2025 (actual)
- Primary completion
- 1 Sep 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 22 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Phase 1: Feasibility RCT
The study is a multi-site, randomised (1:1), controlled, open label, 2 arm, feasibility trial.
DUSTER will be performed in 3 NHS vascular units at the following NHS Trusts:
- Mid and South Essex NHS Foundation Trust
- Imperial College Healthcare NHS Trust
- Manchester University NHS Trust
These sites comprise two urban and one rural site, in both the North, South and East of the country. This will help understand the effects of travel, ethnicity, and geography on attending appointments. Following NIHR INCLUDE guidance we have costed for translation of study materials / interpreters.
Phase 2: Participant interviews
Participants in the intervention arm will be invited to individual semi-structured interviews with members of the research team. The interviews will be held as per participants' preference on MS Teams, or via telephone, or in person, after a minimum 6 month follow up.
The interviews seek to explore factors affecting adherence and the impact of integrated surveillance on patients. It will apply a Qualitative Descriptive Research (QDR) approach and aims to inquire into the experience of everyday living with chronic limb threatening ischaemia. QDR aims to provide broad insight into phenomena as experienced/lived by individuals and is widely used as the qualitative component in mixed-methodology studies especially in large-scale healthcare intervention studies to identify participants' perceptions of why ultrasound surveillance worked or did not work and how it might be better implemented. Using QDR in this manner can make modifications to how surveillance is delivered in a future HTA study, including behavioural modifications such as educational tools, automated reminders along with intervention modifications e.g. community-based scanning.
Phase 3: Participant and stakeholder focus groups
After the feasibility study, we will invite participants and stakeholders to 2 separate focus groups (face to face or MS teams-hybrid) to discuss potential secondary endpoints for a future HTA application (e.g. amputation free survival, quality of life and cost-effectiveness). These will be co-chaired with our lay co-applicants.
HTA application drafting
If progression criteria are met (see , Phases 1 -3 will feed into a draft HTA application in the final month of the study. The progression criteria are:
- >80% of ultrasound surveillance appointments are attended (>72/90), AND
- >90% completion rate of at least one ultrasound scan component (>81/90), AND
- There is an increase of >10% in re-interventions in ultrasound surveillance arm (>3 patients).
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Feasibility Randomised Control Trial
| Arm | Type | Receives |
|---|---|---|
| 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 | Diagnostic Test: Ultrasound SurveillanceWill 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultrasound SurveillanceLower limb arterial ultrasound, ankle and toe blood pressure checks before every in-person clinic appointment at 1, 6 and 12 months. | Diagnostic test | Ultrasound Surveillance Group |
Primary outcome
To assess feasibility of ultrasound surveillance
Time frame: 1 year
* attendance at ultrasound surveillance appointments * completion rates of components of ultrasound surveillance * of participants undergoing arterial reintervention
9 secondary outcomes
Limb Salvage
Time frame: 1 year
Quality of Life
Time frame: 1 Year
Disease specific quality of life
Time frame: 1 Year
Independence in daily activities
Time frame: 1 Year
Participant reported pain
Time frame: 1 Year
Amputations
Time frame: 1 Year
Serious reintervention complications
Time frame: 1 Year
Adverse events (cardiac/cerebrovascular)
Time frame: 1 Year
Mortality
Time frame: 1 Year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2025.
- Derived from this study: PubMed 40784780Gadi 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.
- Individual participant dataSharing planned: Yes. Anonymised outcome data for primary and secondary endpoints to 12 months will be made available for IPD meta-analysis.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ankur Thapar, PhD principal investigator
Mid and South Essex NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound Surveillance in people with Chronic Limb Threatening Ischaemia, run by Mid and South Essex NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 30 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess feasibility of ultrasound surveillance (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06702306, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Dec 2025.