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New automatic device may speed up leg ulcer assessment

NCT ID NCT06557538

Diagnosis Sponsor: University of Southampton Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study compared an automatic ABPI device (MESI MD) with the standard manual device (Huntleigh Dopplex) in 46 patients with lower limb ulcers. The goal was to see if the automatic device gives similar scores and ulcer classifications, potentially reducing waiting times and discomfort. Nurses performed both assessments during routine home or clinic visits in Berkshire.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If the automatic device proves accurate, it could make ABPI assessments faster and more comfortable for patients, saving nursing time.
What could go wrong
This is a small, completed study (46 participants) comparing two devices, not testing a new treatment. Results may not apply to all patients or settings.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

46 people

The number who actually took part.

Started

Sep 2024

Finished

Mar 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

ulcer of lower limbs

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Lower limb ulcers

Contacts and locations

Locations

  • Berkshire Healthcare NHS Foundation Trust

    Bracknell, Berkshire, rg12 2ut, United Kingdom