Multicentre Study to Investigate the Performance of the Padd Device in the Assessment of Peripheral Arterial Disease
|ClinicalTrials.gov Identifier: NCT01633710|
Recruitment Status : Terminated (Redesigned sensor to be subjected to a new protocol)
First Posted : July 4, 2012
Last Update Posted : July 4, 2012
|Condition or disease|
|Peripheral Arterial Disease|
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 Type :||Observational|
|Actual Enrollment :||86 participants|
|Official Title:||Protocol for a Multicentre Study to Investigate the Performance of the Padd Device in the Assessment of Peripheral Arterial Disease|
|Study Start Date :||May 2009|
|Actual Primary Completion Date :||July 2010|
|Actual Study Completion Date :||July 2010|
- Presence or absence of peripheral arterial disease [ Time Frame: 1 day ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|