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New wearable device could revolutionize leg ulcer healing

NCT ID NCT07268482

Symptom relief Sponsor: Feeltect Limited 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a new system called Tight Alright that uses a small wearable device under bandages to measure pressure on leg ulcers. The device sends real-time pressure data to a mobile app and healthcare team, helping ensure the right pressure is applied for healing. About 40 adults with chronic venous leg ulcers will be split into two groups: one gets usual care, the other uses the device plus usual care. Researchers will compare ulcer healing over 90 days to see if the system improves outcomes.

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.

Expected to start

Jan 2026

An estimate. Start dates often move.

Expected to finish

Oct 2026

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: * Adults with chronic venous leg ulcers (≥6-week and ≤5-year durations) currently in compression therapy treatment. * Between 5 and 100 cm2 wound area at randomization. * Ankle brachial pressure index (ABPI) of \>0,8 * Capable of using use a smart device. Exclusion Criteria: * Uncontrolled diabetes \[haemoglobin A1c (HbA1c) ≥12% in the last 3 months\] * Index ulcer has active infection on day of inclusion requiring systemic antibiotic therapy * Renal failure * Exposed tendon, ligament, muscle or bone in the index ulcer * Osteomyelitis, cellulitis or gangrene in study limb * Subjects with an amputation above transmetatarsal in study limb * Active malignancy affecting study limb * Index ulcer is of arterial aetiology (ABPI \<0.8) * Pregnant or breast-feeding women or women of childbearing potential not willing to use a method of highly effective contraception for the duration of the study * Planned vascular surgery, angioplasty or thrombolysis procedures during study period. Or patients who are within six weeks of having had such a procedure * Planned surgical procedure during study period for the index wound * Prior skin replacement, negative-pressure therapy and ultrasound therapy to the study wound in the two weeks before screening * Currently receiving or has received radio or chemotherapy within three months of randomisation * Index wound would require ultrasound near an electronic implant or prosthesis * Not capable of providing informed consent * 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.

ulcer of lower limbs Varicose Ulcer

As listed by the trial registrant

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

Venous leg ulcer (VLU)

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

  • Merlin Park University Hospital

    Galway, Galway, Ireland

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