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Cameras and ultrasound could take the guesswork out of wound care

NCT ID NCT07830849

NEW Diagnosis Sponsor: Scuola Superiore di Studi Universitari e di Perfezionamento Sant'Anna Source: ClinicalTrials.gov ↗

What the study statuses mean

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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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 21, 2026 · Last updated Sep 21, 2026

Summary

Chronic wounds are slow-healing skin injuries often linked to diabetes, poor circulation, or pressure. Doctors usually judge these wounds by eye, which can lead to inconsistent assessments. This pilot study tests whether a combination of non-invasive imaging techniques, including ultrasound, digital photography, infrared thermography, and laser Doppler imaging, can measure wound features more objectively. About 40 adults with pressure or venous ulcers will receive repeated clinical checks and imaging scans, and researchers will compare how well the images agree with standard clinical wound scores.

What this could mean

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

Active substance
Multimodal non-invasive wound imaging (ultrasound, high-resolution digital imaging, infrared thermography, and laser Doppler imaging)
What this could lead to
If it works, doctors could use imaging to track chronic wounds more consistently, which may help tailor treatment and spot healing problems earlier.
What could go wrong
This is a small pilot study with about 40 people, so it can only show whether the approach is feasible. The imaging may not match clinical assessments well enough, and results from a few centers may not apply everywhere.

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 40 people

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

Started

Apr 2026

Expected to finish

Sep 2026

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: * Patients of both sexes aged over 18 years; * Patients with a chronic venous or pressure wound. In the case of venous wounds, the diagnosis must be confirmed by Doppler examination. The wound must have been present for at least 6 weeks and show less than 50% reduction in wound area after 30 days of standard treatment; * Patients with chronic wounds up to Grade III. Exclusion Criteria: * Pregnancy or breastfeeding; * Patients with signs of systemic infection (MEWS \> 0); * Patients with active neoplastic disease, hematological disorders affecting coagulation, or systemic inflammatory autoimmune diseases (e.g., rheumatoid arthritis, systemic lupus erythematosus); * Individuals unable to manage their own interests or provide valid informed consent, even if represented by a legal representative who has provided consent to participation; * Ankle-Brachial Index (ABI) \< 0.8; * Body Mass Index (BMI) \> 40.

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Conditions

The condition(s) this trial relates to.

decubitus ulcer

As listed by the trial registrant

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

Chronic wounds

Contacts and locations

Locations

  • Scuola Superiore Sant'Anna, The BioRobotics Institute

    Pontedera, Pisa, 56025, Italy

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