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Clinical Trials/NCT06557538
NCT06557538CompletedNot Applicable

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

University of Southampton2 sites in 1 country46 target enrollmentStarted: September 16, 2024Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
46
Locations
2
Primary Endpoint
Ankle Brachial Pressure score

Study Overview

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.

Detailed Description

A lower limb ulcer is defined as a non-healing wound, venous disease being the most common cause and the gold standard treatment is compression therapy. The estimated cost implication of managing wounds in the UK is more than £5 billion per year with much of that cost coming from Nursing time and resources Wounds UK classify lower limb ulcers as either a 'Simple venous lower limb ulcer' or 'Complex venous ulcer'. National Institute for Health and Care Excellence states that lower limb ulcer assessments should be holistic including, lower limb, and wound assessments to enable early intervention, increase healing rates, and reduce financial burden. Patients should have an Ankle Brachial Pressure Index (ABPI) measurement assessment which will then give a clinical result to support classification of lower limb ulcers and to establish whether compression therapy is appropriate.

Historically, ABPI has been measured manually using a handheld doppler. This method can be time consuming, unreliable and requires a skilled clinician to undertake it. The test takes between 30 minutes to 1 hour and can also cause significant discomfort for patients with lower limb ulcers as cuffs are placed on limbs and inflated up to four times on each.

With the increasing cost and ageing population, it has been identified that healthcare professionals should be aware of advances in technology and use devices available that are more efficient, providing better patient outcomes. With that said, new automated devices have become available and have been used in community trusts since November 2022. These devices are more time efficient, user friendly and more comfortable for people with lower limb ulcers. The MESI MD ABPI device was introduced into Berkshire Healthcare NHS Foundation Trust (BHFT) in November 2022.

In 2022 NHS England (NHSE) published a Commissioning for Quality and Innovation (CQUIN) guidance with CQUIN targets aimed at ensuring robust, quality wound assessment and reducing deficiencies in intervention and care for patients with lower limb ulcers.

The NHSE CQUIN require 50% of patients with lower limb wound(s) to have a full clinical assessment within 28 days of initial wound presentation and have compression therapy of 40mmHg applied. Following the introduction of the MESI MD ABPI automatic devices to BHFT, the CQUIN achievement results increased by 10%.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • 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

Exclusion Criteria

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

Outcomes

Primary Outcomes

Ankle Brachial Pressure score

Time Frame: Through study completion of average of 7 months

Difference between ABPI scores from automatic and manual ABPI device.

Secondary Outcomes

  • Difference in lower limb ulcer classification(Through study completion of average of 7 months)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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