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ACTIVE NOT RECRUITING
NCT06557538

A Comparison of Automatic ABPI vs Manual ABPI Device Scores

Sponsor: University of Southampton

View on ClinicalTrials.gov

Summary

The aim of the study is to compare the Ankle Brachial Pressure Index (ABPI) scores of two devices. The two devices that will be compared are the MESI MD ABPI automatic device and the Huntleigh Dopplex manual device. The Huntleigh Dopplex manual device is widely used, though the MESI MD ABPI automatic devices can reduce waiting times, reduce discomfort for patients and save nursing time. ABPI devices provide a score that supports nurses to provide suitable treatment for patients with a lower limb ulcer. In the community, patients with lower limb ulcers are offered an ABPI assessment and then treatment is decided based on the score. Participants will be patients with lower limb ulcers referred to community nursing for a lower limb and ABPI assessment. At their routine appointment patients will have a manual assessment and an automatic assessment, and the results will be compared. The study will take place in the county of Berkshire either in patients' homes or in the lower limb clinic. Registered nurses will undertake all assessments. The direct care part of the study will run from July 2024 - December 2024. The data will be pseudonymised, and the findings written as a report that may be sent for publishing.

Official title: Comparing the Ankle Brachial Pressure Index Score of Automatic ABPI Device vs Manual ABPI Device to Classify Lower Limb Ulcers and Guide Treatment in Patients Under Community Services

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

54

Start Date

2024-09-16

Completion Date

2025-03-20

Last Updated

2025-03-06

Healthy Volunteers

No

Interventions

DEVICE

Automatic Ankle Brachial Pressure Index device assessment

The automatic device assesses 3 limbs, providing automatic simultaneous ABPI measurement of systolic, diastolic and mean arterial blood pressure on to calculate the patient\'s ABPI (Medi UK 2022).

DEVICE

Manual Ankle Brachial Pressure Index assessment

The manual device assesses 4 limbs, providing brachial, ankle and pedal systolic pressures. A simple calculation is then made by the clinician to determine the ratio of ankle and brachial systolic pressure (ABPI) (Day 2015).

Locations (1)

Berkshire Healthcare NHS Foundation Trust

Bracknell, Berkshire, United Kingdom