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New ultrasound could revolutionize chronic wound monitoring

NCT ID NCT05739149

Diagnosis Sponsor: Mayo Clinic Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study explores whether a high-resolution ultrasound can better monitor healing in chronic wounds like diabetic foot ulcers. Ten participants will have their wounds scanned and biopsied to see if the ultrasound matches standard assessments. If it works, it could offer a painless way to track healing without invasive procedures.

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 successful, this could lead to a non-invasive way to monitor wound healing, helping doctors adjust treatments earlier.
What could go wrong
This is a very small, early study with only 10 participants, so results may not apply to everyone. The ultrasound method may not prove better than current standard care.

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 10 people

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

Started

Dec 2023

Expected to finish

Dec 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: * Chronic wound in the course of diabetic foot ulcers and/or lower extremity venous ulcers with duration of at least 6 weeks and the wound surface not less than 2 sq. cm and not greater than 15 sq. cm, without evidence of active infection of the wound at the time of qualification to participate in the study * Meets criteria for stalled chronic wound defined as less than 50% reduction in wound size after 30 days of standard of care management. * For chronic venous ulcers, ultrasound demonstrates venous reflux \>0.5 seconds * Satisfactory blood glucose control - fasting not more than 110 mg%, HbA1c \<6.5% * Satisfactory blood supply to the wound verified by the measurement of the oxygen level of the foot tissue (TCPO2 \> 30mmHg) in patients with neuropathic etiology of diabetic foot syndrome * In the case of the patients with the wounds of ischemic component, the condition for qualification is a clinical improvement of the limb's blood supply as a result of the revascularization procedure documented by ultrasound. * Ankle-brachial index (ABI) ≥ 0.8 Exclusion Criteria: * Acute wound with duration less than 6 weeks * Evidence of active infection or on antibiotics * Smoker * For chronic venous ulcers, ultrasound demonstrates venous reflux \<0.5 seconds * Unsatisfactory blood glucose control - fasting more than 110 mg%, HbA1c \<6.5% * Poor blood supply to the wound verified by the measurement of the oxygen level of the foot tissue (TCPO2 \< 30mmHg) in patients with neuropathic etiology of diabetic foot syndrome * Ankle-brachial index (ABI) \< 0. * Pregnancy * Known allergy to lidocaine

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Conditions

The condition(s) this trial relates to.

chronic ulcer of skin ulcer of lower limbs

As listed by the trial registrant

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

Lower extremity wound Non-healing ulcer of skin Non-healing wound

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

  • Mayo Clinic Minnesota

    RECRUITING

    Rochester, Minnesota, 55905, United States

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