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Multicentre Study to Investigate the Performance of the Padd Device in the Assessment of Peripheral Arterial Disease

Peripheral Arterial Disease Clinical Trial

Official title:
Protocol for a Multicentre Study to Investigate the Performance of the Padd Device in the Assessment of Peripheral Arterial Disease

Clinical 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 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.

Clinical Trial 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:

1. Performance: to compare Padd and ABPI for detecting PAD against a gold standard, CDU, performed by an experienced vascular technologist.

2. Safety: to compare adverse events using Padd, ABPI and expert CDU

The secondary objectives are:

1. to compare time taken to perform Padd and ABPI

2. to calculate specificities for Padd and ABPI

3. to investigate the impact of subject posture on the Padd results

4. 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

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01633710
Study type Observational
Source University Hospitals, Leicester
Contact
Status Terminated
Phase N/A
Start date May 2009
Completion date July 2010
View Details
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