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New Light-Based scanner could replace needle tests for leg wounds

NCT ID NCT06899113

Knowledge-focused Sponsor: MIMOSA Diagnostics Inc. 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 26, 2026

Summary

This study is testing whether a new imaging device called MIMOSA Pro can measure oxygen levels in leg tissue as accurately as standard tests like ankle-brachial index or Doppler ultrasound. Researchers will compare the device's readings to those from traditional methods in 60 adults with vascular disease or chronic leg wounds. If successful, the MIMOSA Pro could offer a quicker, non-invasive way to assess blood flow.

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 it works, this could lead to a simpler, faster way to check blood flow in leg wounds without needles or special equipment.
What could go wrong
This is a small, early observational study, not a treatment trial. The new device may not match the accuracy of standard tests, 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.

Participants

About 60 people

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

Started

May 2025

Expected to finish

Dec 2025

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

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

Who is studied

outpatient wound center

Ages

18 years and older

Sex

Anyone

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: * Provision of signed and dated informed consent form * Stated willingness to comply with all study procedures and availability for the duration of the study * Male or female, aged 18 and older * Patient is undergoing an ABI test. * Patient recently had/will have further vascular assessment, as per standard of care (inc. transcutaneous oxygen pressure, Doppler waveforms) * Patients who can be followed by the same investigating team for the whole period of their participation in the study. Exclusion Criteria: * Patients who are participating in another clinical study for ulcer management * Patients who are unable to understand the aims of the study and not able to provide informed consent * Receiving radiation to the extremity * Active charcot joints

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Conditions

The condition(s) this trial relates to.

Foot Ulcer Leg Ulcer peripheral arterial disease peripheral vascular disease ulcer of lower limbs vein disorder

As listed by the trial registrant

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

Chronic wound of the lower limb (leg ulcer or foot ulcer) Vascular disease，peripheral

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

  • Northwell Health Comprehensive Wound Healing Center

    RECRUITING

    Lake Success, New York, 11042, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.