Clinical trial NCT06557538: A Comparison of Automatic ABPI vs Manual ABPI Device Scores
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
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Lower Limb Ulcers
Keywords: Lower limb ulcers
Automatic ankle brachial pressure index
MESI MD ABPI
Huntleigh dopplex
Community
Comparison
ABPI
Lead sponsor: University of Southampton
Sponsor class: OTHER
Collaborators: name: Berkshire Healthcare NHS Foundation Trust
First posted: 2024-08-16
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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%.

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.

1. People using the devices have experience assessing peripheral arterial disease.
2. People using the devices are aware of their limitations, particularly diagnostic accuracy, and the risk of missing peripheral arterial disease, and that there are differences between devices.
3. Further assessment using other methods, including manual doppler, is available.
4. Trusts using devices collect data or do research to assess their value and how well they identify people with peripheral arterial disease.

NICE advised that future research on automated ABPI devices should:

1. Assess their ability to detect peripheral arterial disease in people with leg ulcers
2. Assess how they affect time to treatment for venous leg ulcers
3. Assess clinical outcomes for treatments started after ABPI assessment
4. Explore the most appropriate user (specialist and non-specialist in assessing peripheral arterial disease) and the most appropriate healthcare setting for their use
5. Explore whether different ABPI thresholds can improve their sensitivity for detecting peripheral arterial disease.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Ankle Brachial Pressure score
timeFrame: Through study completion of average of 7 months
Secondary outcomes:
measure: Difference in lower limb ulcer classification
timeFrame: Through study completion of average of 7 months
Other outcomes:
Locations:
city: Bracknell
country: United Kingdom
facility: Berkshire Healthcare NHS Foundation Trust
state: Berkshire
Study officials:
affiliation: School of Health Sciences,University of Southampton,Highfield Campus,University Road,Soton SO17 1BJ
name: Jamal Hossain, PHD
role: STUDY_CHAIR
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