A Comparison of Automatic ABPI vs Manual ABPI Device Scores

NCT06557538 | Active Not Recruiting

• 1 other identifier: ERGO 92967
• Study Type: observational
• Target: 54
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Lower Limb Ulcers

Keywords

Lower limb ulcers; Automatic ankle brachial pressure index; MESI MD ABPI; Huntleigh dopplex; Community; Comparison; ABPI

Outcome Measures

Primary Outcomes (1)

• Ankle Brachial Pressure score

  Difference between ABPI scores from automatic and manual ABPI device.

  Through study completion of average of 7 months

Secondary Outcomes (1)

• Difference in lower limb ulcer classification

  Through study completion of average of 7 months

Study Arms (1)

People over the age of 18 with lower limb ulcers under Community Services

Comparison of reading between automatic and manual device ABPI scores

Device: Automatic Ankle Brachial Pressure Index device assessment; Device: Manual Ankle Brachial Pressure Index assessment

Interventions

Automatic Ankle Brachial Pressure Index device assessment DEVICE

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).

People over the age of 18 with lower limb ulcers under Community Services

Manual Ankle Brachial Pressure Index assessment DEVICE

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).

People over the age of 18 with lower limb ulcers under Community Services

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

People with an open referral to Berkshire community services, living in the county of Berkshire with a lower limb ulcer.

You may qualify if:

• Participants over 18 years old
• Participants will have at least one lower limb ulcer
• Participants will have capacity to consent
• Participants will live in the Geographical area of Berkshire

You may not qualify if:

• Participants found on assessment to have monophasic pulse sounds or signs of aortic stenosis
• Patients deemed to not have capacity to consent

Sponsors & Collaborators

• University of Southampton: lead
• Berkshire Healthcare NHS Foundation Trust: collaborator

Study Sites (1)

Berkshire Healthcare NHS Foundation Trust

Bracknell, Berkshire, rg12 2ut, United Kingdom

Location

Related Publications (20)

• Al-Qaisi M, Nott DM, King DH, Kaddoura S. Ankle brachial pressure index (ABPI): An update for practitioners. Vasc Health Risk Manag. 2009;5:833-41. doi: 10.2147/vhrm.s6759. Epub 2009 Oct 12.

  PMID: 19851521 BACKGROUND

• Boast, G., Green, J., Chambers, R. and Calderwood, R. (2019) 'Improving assessment and management of lower limb wounds', Journal of community nursing,33 (5), pp. 34 - 38

  BACKGROUND

• Benbow M. An introduction and guide to effective Doppler assessment. Br J Community Nurs. 2014 Dec;Suppl Wound Care:S21-6. doi: 10.12968/bjcn.2014.19.Sup3.S21.

  PMID: 25478852 BACKGROUND

• Buxey, K. (2020) 'Introducing MESI ABPI MD automated device to a leg club setting', Journal of Community Nursing, 34 (1), pp. 22- 26

  BACKGROUND

• Day J. Diagnosing and managing venous leg ulcers in patients in the community. Br J Community Nurs. 2015 Dec;20 Suppl 12:S22-30. doi: 10.12968/bjcn.2015.20.Sup12.S22.

  PMID: 26639070 BACKGROUND

• Dowsett, C. and Taylor, C. (2018) 'Reducing variation in leg ulcer assessment management using quality improvement methods', Wounds UK, 14 (4), pp. 46 - 51

  BACKGROUND

• Boyers, D., Cruickshank, M., Aucott, L., Kennedy, C., Manson, P., Bachoo, P. and Brazelli, M (2022) Automated measurement of ankle brachial pressure index for assessing the presence of peripheral arterial disease in people with leg ulceration, University of Aberdeen Report. Available at: diagnostics-assessment-report

  BACKGROUND

• Faul F, Erdfelder E, Lang AG, Buchner A. G*Power 3: a flexible statistical power analysis program for the social, behavioral, and biomedical sciences. Behav Res Methods. 2007 May;39(2):175-91. doi: 10.3758/bf03193146.

  PMID: 17695343 BACKGROUND

• Grove, SK., Gray, JR. and Burns, N. (2019) Understanding Nursing Research: Building an Evidence-Based Practice. St. Louis, Missouri: Elsevier

  BACKGROUND

• Lloyd- Jones, M. (2019) 'Wound Care: What's new? 1. Ankle and brachial pressure index in practice', British journal of Healthcare Assistants, 13 (9), pp. 422- 426

  BACKGROUND

• Medi UK Ltd. (2022) Instructions for use: MESI ABPI MD, Ankle Brachial Pressure Index. Available at: www.mediuk.co.uk

  BACKGROUND

• Moffat, C., Martin, R. and Smithdale, R. (2007) Leg Ulcer Management. Oxford: Blackwell publishing

  BACKGROUND

• National Health Service England (NHSE) (2022) Commissioning for Quality and Innovation (CQUIN): 2023/24 guidance. Available at: https://www.england.nhs.uk/nhs-standard-contract/cquin/cquin-23-24/

  BACKGROUND

• Guest JF, Ayoub N, McIlwraith T, Uchegbu I, Gerrish A, Weidlich D, Vowden K, Vowden P. Health economic burden that wounds impose on the National Health Service in the UK. BMJ Open. 2015 Dec 7;5(12):e009283. doi: 10.1136/bmjopen-2015-009283.

  PMID: 26644123 BACKGROUND

• Lindsay, E. and Whiteley, M. (2018) A partnership approach: helping patients with leg ulcers and varicose veins', Wounds UK, 14 (3), pp. 86- 88

  BACKGROUND

• Rayaa, R., Martíneza, N., Cayuelasa, F., Perab, G. and García, Y. (2019) 'Comparison of two automatic oscillometers vs the traditional method with Doppler probe in the determination of the ankle brachial index', Atencion Primaria Practica, 1(1), pp 3- 8

  BACKGROUND

• Span M, Gersak G, Millasseau SC, Meza M, Kosir A. Detection of peripheral arterial disease with an improved automated device: comparison of a new oscillometric device and the standard Doppler method. Vasc Health Risk Manag. 2016 Jul 29;12:305-11. doi: 10.2147/VHRM.S106534. eCollection 2016.

  PMID: 27536125 BACKGROUND

• Wounds UK (2016) Best Practice Statement: Holistic Management of Venous Leg Ulceration. Available at: Venous Leg Ulceration.indd (wounds-uk.com)

  BACKGROUND

• University of Southampton (2012) University Ethics Policy. Available at: University Ethics Policy | University of Southampton

  BACKGROUND

• Wounds UK (2019) Best Practice Statement Ankle Brachial pressure index (ABPI) in practice. Available at https://wounds-uk.com/best-practice-statements/ankle-brachial-pressure-index-abpi-practice/

  BACKGROUND

Related Links

• NICE guidance relevant to study background
• NICE guidance relevant to study background
• CQUIN guidance

Study Officials

• Jamal Hossain, PHD

  School of Health Sciences,University of Southampton,Highfield Campus,University Road,Soton SO17 1BJ

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 7, 2024
• First Posted: August 16, 2024
• Study Start: September 16, 2024
• Primary Completion: December 24, 2024
• Study Completion: March 20, 2025
• Last Updated: March 6, 2025

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP, CSR, ANALYTIC CODE
• Time Frame: Anonymous data indefinitely
• Access Criteria: Researchers connected with the University of Southampton and Berkshire Healthcare Foundation Trust.

Locations

GB (1)