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.
Peripheral Arterial Disease
|Study Design:||Observational Model: Case-Only
Time Perspective: Cross-Sectional
|Official Title:||Protocol for a Multicentre Study to Investigate the Performance of the Padd Device in the Assessment of Peripheral Arterial Disease|
- Presence or absence of peripheral arterial disease [ Time Frame: 1 day ] [ Designated as safety issue: No ]
|Study Start Date:||May 2009|
|Study Completion Date:||July 2010|
|Primary Completion Date:||July 2010 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01633710
|University of Leicester|
|Leicester, Leicestershire, United Kingdom, LE1 6TP|
|Royal Free Hospital|
|London, United Kingdom, NW3 2QG|
|Principal Investigator:||Kamlesh Khunti, MB BS||University of Leicester|