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Novel pulse device for diagnosis of peripheral arterial disease (NOTEPAD)

Innovative photoplethysmography technology for rapid non-invasive assessment of peripheral arterial disease in primary care (NOTEPAD)

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ISRCTN
Registry ID
ISRCTN13301188
Enrollment
250
Registered
2016-10-13
Start date
2015-05-13
Completion date
Unknown
Last updated
2022-11-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Peripheral arterial disease (PAD) Circulatory System Peripheral arterial disease (PAD)

Interventions

GP Practices will identify eligible patients and send invite letters in the post. Once an invite is accepted, the GP Practice will match the PAD patient with a control (matched by age and sex) and sen

Sponsors

Newcastle upon Tyne Hospitals NHS Foundation Trust
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patients: 1. Aged 45 years and over 2. Provision of informed consent 3. Diagnosed with PAD Controls: 1. Aged 45 years and over 2. Provision of informed consent 3. Not diagnosed with PAD

Exclusion criteria

Exclusion criteria: 1. Those under 45 years of age 2. Those unable to provide informed consent. 3. Individuals with renal failure receiving renal support therapy (ESRF) 4. Patients with tender or painful calves, ankles or feet who would be unable to tolerate ABPI measurements (ulcerated legs) 5. Toe/limb amputees (bilateral comparisons needed to make pulse and pressure-based assessments) 6. PPG measurement site (big toe pad, index finger pad, earlobe) having any visible damage to local skin area (skin needs to be intact) 7. Significant limb tremor 8. Patients unable to understand English sufficiently to give informed consent

Design outcomes

Primary

MeasureTime frame
Diagnostic accuracy of MPPG and ABPI with each compared with Duplex scan using values of sensitivity, specificity, and positive and negative predictive values.

Secondary

MeasureTime frame
No secondary outcome measures.

Countries

England, United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 19, 2026