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

This study has been terminated.
(Redesigned sensor to be subjected to a new protocol)
Sponsor:
Information provided by:
University Hospitals, Leicester
ClinicalTrials.gov Identifier:
NCT01633710
First received: July 16, 2009
Last updated: July 3, 2012
Last verified: June 2012
  Purpose

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.


Condition
Peripheral Arterial Disease

Study Type: Observational
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

Resource links provided by NLM:


Further study details as provided by University Hospitals, Leicester:

Primary Outcome Measures:
  • Presence or absence of peripheral arterial disease [ Time Frame: 1 day ] [ Designated as safety issue: No ]

Enrollment: 86
Study Start Date: May 2009
Study Completion Date: July 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
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:

  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.

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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.

Criteria

Inclusion criteria:

  1. Royal Free Hospital - patients >50 years old referred to the vascular clinic for suspected peripheral arterial disease
  2. 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)

Exclusion Criteria:

  1. bilateral amputation that precludes placement of the Padd sensors on the feet
  2. acute deep venous thrombosis, within the previous six months (application of ABPI pressure cuff on legs is not advisable for these patients)
  3. skin damage or infection that precludes placement of sensors
  4. active psychotic illness or severe cognitive impairment
  5. inability to lie supine
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01633710

Locations
United Kingdom
University of Leicester
Leicester, Leicestershire, United Kingdom, LE1 6TP
Royal Free Hospital
London, United Kingdom, NW3 2QG
Sponsors and Collaborators
University Hospitals, Leicester
Investigators
Principal Investigator: Kamlesh Khunti, MB BS University of Leicester
  More Information

No publications provided

Responsible Party: Professor Kamlesh Khunti, University of Leicester
ClinicalTrials.gov Identifier: NCT01633710     History of Changes
Other Study ID Numbers: DDL-2009-01
Study First Received: July 16, 2009
Last Updated: July 3, 2012
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by University Hospitals, Leicester:
Ankle brachial pressure index
Colour duplex ultrasound
Diabetes
Photoplethysmography

Additional relevant MeSH terms:
Peripheral Arterial Disease
Peripheral Vascular Diseases
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on July 23, 2014