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A simple handheld test could spot hidden artery trouble in diabetic foot wounds

NCT ID NCT07732270

Diagnosis Sponsor: Groupe Hospitalier de la Rochelle Ré Aunis 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 This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 28, 2026 · Last updated Jul 29, 2026 · Updated 1 time

Summary

This trial tests whether a portable handheld Doppler device can help nurses quickly detect arterial insufficiency in people with diabetes who have foot ulcers. The device checks for blood flow in the great toe, and the goal is to see if it can reliably flag patients who need further vascular testing. If accurate, this simple tool could speed up care and reduce the risk of amputation.

What this could mean

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

Active substance
handheld Doppler device used to detect blood flow in the great toe
What this could lead to
If it works, this quick test could help nurses identify which diabetic foot ulcers need urgent vascular specialist care, potentially preventing amputations.
What could go wrong
This is a small, early-stage diagnostic study. The device may not be accurate enough to replace standard vascular assessments, and results may not apply to all patients.

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.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 84 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Sep 2028

An estimate. End dates often move.

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.

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: * Patient aged ≥18 years, * Patient with type 1 or type 2 diabetes, * Patient with a foot ulcer on one or both feet, regardless of the duration of diabetes (each limb will be considered hemodynamically independent, as the vast majority of arterial lesions in patients with diabetes are located below the inguinal ligament), * Participant affiliated with or beneficiary of a social security scheme, * Written informed consent obtained from the participant and the investigator no later than the day of inclusion and before any study-specific procedure Exclusion Criteria: * Patient with suspected distal thromboembolic disease of the lower limbs, * Patient with suspected non-atherosclerotic peripheral arterial disease of the lower limbs (Buerger's disease, cannabis-associated arteriopathy, vasculitis, etc.), * Patient who has previously undergone a revascularization procedure, * Patient with an acute form of lower limb peripheral arterial occlusive disease, * Patient with severe sepsis, * Patient with no remaining great toes, * Person under enhanced protection, including minors, persons deprived of liberty by judicial or administrative decision, and adults under legal protection, * Pregnant and/or breastfeeding women, * Patient unable to provide informed consent, * Patient refusing to participate

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Conditions

The condition(s) this trial relates to.

arterial disorder Diabetic Foot peripheral arterial disease peripheral ischemia vascular insufficiency disorder

As listed by the trial registrant

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

Arterial insufficiency

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Groupe Hospitalier de La Rochelle Ré Aunis

    La Rochelle, France, 17000, France

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