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Smart mat could help diabetics avoid foot ulcers

NCT ID NCT05968924

Knowledge-focused Sponsor: Montefiore Medical Center 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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tested whether people with diabetes would use a special foot mat at home every day. The mat, called the Podimetrics SmartMat, measures foot temperature to spot early signs of foot ulcers. Twenty people who had a foot ulcer in the past used the mat for six months. The main goal was to see if they would stick with using it, not whether it actually prevented ulcers.

What this could mean

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

Active substance
Podimetrics SmartMat (a foot mat device)
What this could lead to
If successful, this could lead to a simple home tool that helps people with diabetes catch foot ulcers early, preventing serious complications.
What could go wrong
This was a very small study (20 people) focused on whether people would use the mat regularly, not on whether it actually prevents ulcers. Larger studies are needed to prove it works.

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

20 people

The number who actually took part.

Started

Jul 2024

Finished

Apr 2025

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 to 75 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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: 1. Type 1 or Type 2 diabetes mellitus 2. Prior treatment of DFU within 24 months 3. Subject had at least one outpatient follow up with a provider after treatment for DFU 4. No active ulcer at time of enrollment 5. Male or female, aged 18-75 yrs 6. Presence of Neuropathy 7. Ambulatory 8. Provision of signed and dated informed consent form 9. Stated willingness to adhere with all study procedures and availability to participate for the duration of the study Exclusion Criteria: 1. Active diabetic foot ulcer (DFU) 2. Unable to comply with study requirements 3. Prior above-knee amputation (AKA) or below-knee amputation (BKA)

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Conditions

The condition(s) this trial relates to.

Diabetes Complications diabetes mellitus Diabetic Foot Foot Ulcer

As listed by the trial registrant

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

Diabetic foot ulcer

Contacts and locations

Locations

  • Montefiore Medical Center

    The Bronx, New York, 10461, United States

More trials for these conditions

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