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Wearable sensor could take the guesswork out of leg ulcer treatment

NCT ID NCT07152717

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 10, 2026 · Updated 3 times

Summary

This study tests a wearable device called Tight Alright that measures pressure under compression bandages for venous leg ulcers. Standard compression therapy is effective but hard to get right without feedback. The device sends pressure data to a phone app, helping clinicians and patients apply and maintain the right pressure. The trial will compare wound healing in 40 people who use the device versus those who don't.

What this could mean

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

Active substance
Tight Alright wearable pressure sensor device
What this could lead to
If it works, this could make compression therapy more consistent and effective, potentially speeding up healing of venous leg ulcers.
What could go wrong
This is a small, early-stage study with only 40 participants, so results may not apply to everyone. The device may not significantly improve healing rates or patient adherence.

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

Nov 2025

Expected to finish

Mar 2027

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.

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 of Parkview Noble Center for Wound Healing * Adults 18+ with venous leg ulcers receiving compression therapy treatment prescribed by outpatient wound clinic. * Capable of using use a smart device * Owns a smart phone or device capable of downloading the Mobile App Exclusion Criteria: * \<18 years old * Unable to consent in English * Cellulitis in affected limb * Acute deep vein thrombosis in affected limb * Active malignancy in affected limb * Prisoners * Currently enrolled in or has been enrolled in another investigation device or drug trial in the last 30 days

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

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

  • Parkview Center for Wound Healing

    RECRUITING

    Fort Wayne, Indiana, 46805, United States

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