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

NCT01633710 | Terminated

• 1 other identifier: DDL-2009-01
• Study Type: observational
• Target: 86
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Peripheral Arterial Disease

Keywords

Ankle brachial pressure index; Colour duplex ultrasound; Diabetes; Photoplethysmography

Outcome Measures

Primary Outcomes (1)

• Presence or absence of peripheral arterial disease

  1 day

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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
• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospitals, Leicester: lead

Study Sites (2)

University of Leicester

Leicester, Leicestershire, LE1 6TP, United Kingdom

Location

Royal Free Hospital

London, London, NW3 2QG, United Kingdom

Location

MeSH Terms

Conditions

Peripheral Arterial Disease; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Kamlesh Khunti, MB BS

  University of Leicester

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 16, 2009
• First Posted: July 4, 2012
• Study Start: May 1, 2009
• Primary Completion: July 1, 2010
• Study Completion: July 1, 2010
• Last Updated: July 4, 2012

Record last verified: 2012-06

Locations

GB (2)