An observational study in Lower Limb Ulcers, sponsored by University of Southampton. Completed at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-18.
Sponsored by University of Southampton · Observational
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.
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%.
Due to the impact of introducing the MESI MD ABPI device BHFT wished to continue with their use. NICE published the guidance on usage of automatic ABPI measurement devices in people with lower limb ulcers. They identified that there is a lack of evidence on the accuracy of automated ABPI devices. They provided a criterion for Trusts who want to continue using these devices. It was identified that the trust met all NICE criteria except for Criteria. Therefore, BHFT agreed to support an research study project on the MESI MD ABPI device to compare its agreement with results of the manual doppler.
As an advanced clinician expected to be competent in the four pillars of advanced practice including research, I agreed this would be an appropriate study for me to undertake as it would benefit both my development, and patients under our care.
NICE Criterion for continued use of automatic ABPI devices.
NICE advised that future research on automated ABPI devices should:
There are several studies and anecdotal evidence that the automatic devices save time and reduce time to treatment in line with CQUIN standards. However, there is dearth of research on the efficacy of the automatic devices and therefore, it was decided to undertake a study on comparing the results of the automatic to the validated manual device to fulfil criteria one.
University of Southampton is the lead sponsor of 121 studies on the registry; 19 are open to participants now.
Counted across the registry records on this site, refreshed daily.
People with an open referral to Berkshire community services, living in the county of Berkshire with a lower limb ulcer.
Exclusion Criteria:
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
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).
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).
Ankle Brachial Pressure score
Difference between ABPI scores from automatic and manual ABPI device.
Time frame: Through study completion of average of 7 months
Difference in lower limb ulcer classification
Difference in lower limb ulcer classification between automatic and manual ABPI device.
Time frame: Through study completion of average of 7 months
Plan to share: Yes — Anonymised data will be held in the University repository and be available for use in future study.
Supporting information: Sap, Csr, Analytic code
This study is completed, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.
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