Standardised Claudication Treadmill TestEMMUNCT02086331
Evaluation of Musculoskeletal Microcirculation With Ultrasound
A study testing Contrast enhanced ultrasound and Treadmill test in people with Standardised Claudication Treadmill Test, run by Imperial College London at 1 site in United Kingdom.
Trial summary
This study aims to validate the use of Dynamic Contrast-Enhanced Ultrasound in measuring the blood supply to the muscles of the leg, and how this changes with exercise and vascular pathology. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Standardised Claudication Treadmill Test
- What is being tested?
- Contrast enhanced ultrasound and Treadmill test
- Type of treatment
- Injection or infusion, Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Dec 2013to Dec 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Personal history of diabetes or peripheral arterial disease, current pregnancy, previous surgery to the lower limb, heart attack within 4 weeks, or unstable angina
- Group 2 - Peripheral arterial disease subjects Inclusion
- 18+ years old, radiological evidence of peripheral arterial disease (arterial doppler or angiogram), ankle-brachial pressure index (ABPI) 0.5-0.8
- Personal history of diabetes, current pregnancy, previous amputation, heart attack within 4 weeks, or unstable angina
- Group 3 - Diabetic subjects Inclusion
- 18+ years old, with a clinical diagnoses of diabetes (1, 2)
- ABPI<0.9, previous amputation, current pregnancy or breastfeeding, heart attack within 4 weeks, or unstable angina.
Trial locations and contacts
1 site in 1 country.
About this study
This study aims to validate the use of Dynamic Contrast-Enhanced Ultrasound in measuring the blood supply to the muscles of the leg, and how this changes with exercise and vascular pathology.
Read the detailed description
We propose a model for the use of Dynamic Contrast-Enhanced Ultrasound (DCEU) to directly evaluate the microcirculation of the musculoskeletal system. We believe that this will be a valuable research tool into diseases of the microcirculation, and in the future may also offer a clinical benefit by quantifying and monitoring disease over time and after intervention. It may also allow targeting of therapies towards those patients most at risk of ulcers and peripheral neuropathy, and those that would get the maximum benefit from these therapies.
- Conditions
- Standardised Claudication Treadmill Test
- Being tested
- Contrast enhanced ultrasound, Treadmill test
- Keywords
- treadmill test
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Contrast enhanced ultrasoundProcedure or surgery
Infusion of microbubbles to enhance blood vessels in the leg for ultrasound
Treadmill testBehavioural
Exposes you to exercise in a controlled environment. We will see if we can detect this change with our new ultrasound protocol
Contrast enhanced ultrasoundProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Healthy | Active comparator | Healthy volunteers, deemed to have normal metabolic and cardiovascular biology by trial criteria Receives: Procedure: Contrast enhanced ultrasound; Behavioral: Treadmill test |
| PAD | Active comparator | Symptomatic peripheral arterial disease Receives: Procedure: Contrast enhanced ultrasound; Behavioral: Treadmill test |
| DM | Active comparator | Symptomatic diabetic peripheral neuropathy Receives: Procedure: Contrast enhanced ultrasound; Behavioral: Treadmill test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Threshold of High to Low Frequency Ratio (Threshold HLFR)
Please see published article for in depth method. This ratio is used to classify a given signal as either microbubble or noise. For a pixel containing a micro vessel, as microbubbles occasionally pass this otherwise dark pixel, its temporal signal is expected to have a higher proportion of lower frequency components than white noise. Consequently, the HLFR of the pixel is expected to be smaller than that of noise. A histogram of normalised HLFR shows two expected peaks (one noise, one bubbles). A threshold (Threshold HLFR) is determined to then separate the two peaks. this is done using a double Gaussian model, and where they intercept is deemed the Threshold HLFR.
Measured: Baseline, 20 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2014 (estimated)
- Study startDec 2013
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Standardised Claudication Treadmill TestStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe sponsor's other registered studies.
- 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
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Prof AH Davies, Principal investigator, Imperial College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02086331
- Sponsor's protocol ID
- 13/LO/0943
- Other IDs
- 13HH0684
- Acronym
- EMMU
- Status last verified
- Nov 2020
- First submitted
- 9 Jan 2014
- Last updated
- 25 Nov 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Musculoskeletal Microcirculation With Ultrasound
- ClinicalTrials.gov ID
- NCT02086331
- Acronym / sponsor ID
- EMMU / 13/LO/0943
- Conditions
- Standardised Claudication Treadmill Test
- Keywords
- treadmill test
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Study start
- Dec 2013 (actual)
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 13 Mar 2014 (estimated)
- Results
- Posted 25 Nov 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to validate the use of Dynamic Contrast-Enhanced Ultrasound in measuring the blood supply to the muscles of the leg, and how this changes with exercise and vascular pathology.
Detailed description
We propose a model for the use of Dynamic Contrast-Enhanced Ultrasound (DCEU) to directly evaluate the microcirculation of the musculoskeletal system. We believe that this will be a valuable research tool into diseases of the microcirculation, and in the future may also offer a clinical benefit by quantifying and monitoring disease over time and after intervention. It may also allow targeting of therapies towards those patients most at risk of ulcers and peripheral neuropathy, and those that would get the maximum benefit from these therapies.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Healthy | Active comparator | Procedure: Contrast enhanced ultrasound, Behavioral: Treadmill testHealthy volunteers, deemed to have normal metabolic and cardiovascular biology by trial criteria |
| PAD | Active comparator | Procedure: Contrast enhanced ultrasound, Behavioral: Treadmill testSymptomatic peripheral arterial disease |
| DM | Active comparator | Procedure: Contrast enhanced ultrasound, Behavioral: Treadmill testSymptomatic diabetic peripheral neuropathy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (7 listed)
- Personal history of diabetes or peripheral arterial disease, current pregnancy, previous surgery to the lower limb, heart attack within 4 weeks, or unstable angina
- Group 2 - Peripheral arterial disease subjects Inclusion
- 18+ years old, radiological evidence of peripheral arterial disease (arterial doppler or angiogram), ankle-brachial pressure index (ABPI) 0.5-0.8
- Personal history of diabetes, current pregnancy, previous amputation, heart attack within 4 weeks, or unstable angina
- Group 3 - Diabetic subjects Inclusion
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 |
|---|---|---|
| Contrast enhanced ultrasoundInfusion of microbubbles to enhance blood vessels in the leg for ultrasound | Procedure or surgery | DM, Healthy, PAD |
| Treadmill testExposes you to exercise in a controlled environment. We will see if we can detect this change with our new ultrasound protocol | Behavioural | DM, Healthy, PAD |
| Contrast enhanced ultrasound | Procedure or surgery | DM, Healthy, PAD |
Primary outcome
Threshold of High to Low Frequency Ratio (Threshold HLFR)
Time frame: Baseline, 20 minutes
Please see published article for in depth method. This ratio is used to classify a given signal as either microbubble or noise. For a pixel containing a micro vessel, as microbubbles occasionally pass this otherwise dark pixel, its temporal signal is expected to have a higher proportion of lower frequency components than white noise. Consequently, the HLFR of the pixel is expected to be smaller than that of noise. A histogram of normalised HLFR shows two expected peaks (one noise, one bubbles). A threshold (Threshold HLFR) is determined to then separate the two peaks. this is done using a double Gaussian model, and where they intercept is deemed the Threshold HLFR.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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.
Prof AH Davies principal investigator
Imperial College London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Contrast enhanced ultrasound and Treadmill test in people with Standardised Claudication Treadmill Test, run by Imperial College London 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 0 inclusion and 7 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: stopped early, as of the sponsor's last update on 25 Nov 2020. 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?
Yes. Results are posted in the registry (first posted 25 Nov 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Threshold of High to Low Frequency Ratio (Threshold HLFR) (time frame: Baseline, 20 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Nov 2020.