Peripheral Arterial DiseaseNCT01633710
Multicentre Study to Investigate the Performance of the Padd Device in the Assessment of Peripheral Arterial Disease
An observational study of Peripheral Arterial Disease, run by University Hospitals, Leicester at 2 sites in United Kingdom.
Trial summary
The study will compare Padd, a non-invasive automated optical device which uses a functional test to assess peripheral arterial disease (PAD), and Ankle brachial pressure index (ABPI) in the detection of PAD using as a gold standard, colour duplex ultrasound, in participants drawn from general practice, a hospital… Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Peripheral Arterial Disease
- How many people
- 86 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- May 2009to Jul 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients of 50 or over attending a vascular clinic at a major London hospital; patients of 70 years or over or 50-69 years with a history of diabetes, smoking, known peripheral arterial disease or at least 2 risk factors (previous ischaemic event, hyperlipidaemia, hypertension, family history of cardiovascular disease) from both primary and secondary care.
Who may be able to join
- Royal Free Hospital - patients >50 years old referred to the vascular clinic for suspected peripheral arterial disease
- Leicester
- age 70 years or older
- age 50-69 years with a history of smoking, diabetes or peripheral arterial disease
- 50-69 years with at least two peripheral arterial disease risk factors (hyperlipidaemia, hypertension, family history of cardiovascular disease, previous ischaemic event: myocardial infarction, stroke and TIA)
Who cannot join
- bilateral amputation that precludes placement of the Padd sensors on the feet
- acute deep venous thrombosis, within the previous six months (application of ABPI pressure cuff on legs is not advisable for these patients)
- skin damage or infection that precludes placement of sensors
- active psychotic illness or severe cognitive impairment
- inability to lie supine
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
University of Leicester
Leicester, Leicestershire, LE1 6TP
Royal Free Hospital
London, London, NW3 2QG
About this study
Official title: Protocol for a Multicentre Study to Investigate the Performance of the Padd Device in the Assessment of Peripheral Arterial Disease
The study will compare Padd, a non-invasive automated optical device which uses a functional test to assess peripheral arterial disease (PAD), and Ankle brachial pressure index (ABPI) in the detection of PAD using as a gold standard, colour duplex ultrasound, in participants drawn from general practice, a hospital diabetic clinic and a tertiary vascular disease referral centre. The study hypothesis is that Padd performs at least as well as ABPI in detecting PAD.
Read the detailed description
400 participants, with a minimum of 200 participants per site, will be recruited from two centres. At the Royal Free Hospital, London, the inclusion criterion is simply attendance at the vascular clinic; in Leicester patients >70 years or 50-69 years with a history of diabetes, smoking, known PAD or at least 2 risk factors (previous ischaemic event, hyperlipidaemia, hypertension, family history of cardiovascular disease) will be recruited from both primary care and the hospital diabetes clinic. The anticipated peripheral arterial disease detection rates are approximately 75% in London and 25% in Leicester.
In addition to standard questionnaires, participants will undergo bilateral Padd and resting ABPI. CDU will be performed by an accredited vascular technologist who will employ a scoring method consistent between both sites. The vascular technologist will be blind to the Padd and ABPI results. The results obtained with Padd and ABPI will be compared with CDU as the gold standard for this study.
The primary objectives are:
- Performance: to compare Padd and ABPI for detecting PAD against a gold standard, CDU, performed by an experienced vascular technologist.
- Safety: to compare adverse events using Padd, ABPI and expert CDU
The secondary objectives are:
- to compare time taken to perform Padd and ABPI
- to calculate specificities for Padd and ABPI
- to investigate the impact of subject posture on the Padd results
- to determine if skin colour has any impact on Padd performance
There are no treatments or interventions determined exclusively from the Padd readings.
- Conditions
- Peripheral Arterial Disease
- Keywords
- Ankle brachial pressure index, Colour duplex ultrasound, Diabetes, Photoplethysmography
- Medical subject headings
- Peripheral Arterial Disease, Diabetes Mellitus
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence or absence of peripheral arterial disease
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2012 (estimated)
- Study startMay 2009
- Primary completionJul 2010
- Study completionJul 2010
Why it stopped: Redesigned sensor to be subjected to a new protocol
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Arterial DiseaseStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospitals, Leicester
- Sponsor type
- University, hospital or other
- Investigators
- Kamlesh Khunti, MB BS, Principal investigator, University of Leicester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01633710
- Sponsor's protocol ID
- DDL-2009-01
- Status last verified
- Jun 2012
- First submitted
- 16 Jul 2009
- Last updated
- 4 Jul 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Protocol for a Multicentre Study to Investigate the Performance of the Padd Device in the Assessment of Peripheral Arterial Disease
- ClinicalTrials.gov ID
- NCT01633710
- Acronym / sponsor ID
- DDL-2009-01
- Conditions
- Peripheral Arterial Disease
- Keywords
- Ankle brachial pressure index, Colour duplex ultrasound, Diabetes, Photoplethysmography
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Redesigned sensor to be subjected to a new protocol
- Enrolment
- 86 participants (actual)
- Lead sponsor
- University Hospitals, LeicesterUniversity, hospital or other
- Study start
- May 2009
- Primary completion
- Jul 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 4 Jul 2012 (estimated)
- 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.
The study will compare Padd, a non-invasive automated optical device which uses a functional test to assess peripheral arterial disease (PAD), and Ankle brachial pressure index (ABPI) in the detection of PAD using as a gold standard, colour duplex ultrasound, in participants drawn from general practice, a hospital diabetic clinic and a tertiary vascular disease referral centre. The study hypothesis is that Padd performs at least as well as ABPI in detecting PAD.
Detailed description
400 participants, with a minimum of 200 participants per site, will be recruited from two centres. At the Royal Free Hospital, London, the inclusion criterion is simply attendance at the vascular clinic; in Leicester patients >70 years or 50-69 years with a history of diabetes, smoking, known PAD or at least 2 risk factors (previous ischaemic event, hyperlipidaemia, hypertension, family history of cardiovascular disease) will be recruited from both primary care and the hospital diabetes clinic. The anticipated peripheral arterial disease detection rates are approximately 75% in London and 25% in Leicester.
In addition to standard questionnaires, participants will undergo bilateral Padd and resting ABPI. CDU will be performed by an accredited vascular technologist who will employ a scoring method consistent between both sites. The vascular technologist will be blind to the Padd and ABPI results. The results obtained with Padd and ABPI will be compared with CDU as the gold standard for this study.
The primary objectives are:
- Performance: to compare Padd and ABPI for detecting PAD against a gold standard, CDU, performed by an experienced vascular technologist.
- Safety: to compare adverse events using Padd, ABPI and expert CDU
The secondary objectives are:
- to compare time taken to perform Padd and ABPI
- to calculate specificities for Padd and ABPI
- to investigate the impact of subject posture on the Padd results
- to determine if skin colour has any impact on Padd performance
There are no treatments or interventions determined exclusively from the Padd readings.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients of 50 or over attending a vascular clinic at a major London hospital; patients of 70 years or over or 50-69 years with a history of diabetes, smoking, known peripheral arterial disease or at least 2 risk factors (previous ischaemic event, hyperlipidaemia, hypertension, family history of cardiovascular disease) from both primary and secondary care.
Key inclusion criteria (5 listed)
- Royal Free Hospital - patients >50 years old referred to the vascular clinic for suspected peripheral arterial disease
- Leicester
Key exclusion criteria (5 listed)
- bilateral amputation that precludes placement of the Padd sensors on the feet
- acute deep venous thrombosis, within the previous six months (application of ABPI pressure cuff on legs is not advisable for these patients)
- skin damage or infection that precludes placement of sensors
- active psychotic illness or severe cognitive impairment
- inability to lie supine
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Presence or absence of peripheral arterial disease
Time frame: 1 day
Results and safety
The study was stopped early (reason given: Redesigned sensor to be subjected to a new protocol). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jul 2012.
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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.
Kamlesh Khunti, MB BS principal investigator
University of Leicester
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Peripheral Arterial Disease, run by University Hospitals, Leicester at 2 sites 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 5 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 4 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The study was stopped early (reason given: Redesigned sensor to be subjected to a new protocol). Results are not available in the source record.
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?
Presence or absence of peripheral arterial disease (time frame: 1 day). 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 4 Jul 2012.