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Smart mat could help veterans avoid diabetic foot ulcers

NCT ID NCT05728411

Disease control Sponsor: VA Office of Research and Development 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 23, 2026 · Updated 5 times

Summary

This study tests a smart mat that checks foot temperature at home to catch early signs of damage in high-risk diabetes patients. 800 Veterans with a history of foot ulcers or amputation will use the mat for up to 24 months. The goal is to see if this technology can prevent new ulcers and reduce amputations.

What this could mean

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

Active substance
Remote foot temperature monitoring system (smart mat)
What this could lead to
If it works, this could give high-risk diabetes patients a simple, home-based way to catch early signs of foot ulcers and prevent them from forming.
What could go wrong
This is a relatively early-stage test in a specific VA population. The mat may not reduce ulcers as hoped, and results may not apply to all diabetes 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.

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

379 people

The number who actually took part.

Started

Oct 2023

Expected to finish

Dec 2031

An estimate. End dates often move.

Lead sponsor

A government agency

The lead sponsor is a US federal agency other than the NIH.

Who can take part

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

Ages

18 to 89 years

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: * Veteran * Diabetes diagnosis * History of foot ulcer (including active ulcer) OR history of lower extremity amputation (including unhealed amputation) * Able to understand/read English Exclusion Criteria: * Dementia * Unable to ambulate * Bilateral lower extremity amputation * Ankle brachial index \<0.6 or toe brachial index \<0.5 * Currently using in-home temperature monitoring * Prisoner

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Conditions

The condition(s) this trial relates to.

diabetes mellitus Diabetic Foot

As listed by the trial registrant

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

Diabetic foot

Contacts and locations

Locations

  • Edward Hines Jr. VA Hospital, Hines, IL

    Hines, Illinois, 60141-3030, United States

  • Richmond VA Medical Center, Richmond, VA

    Richmond, Virginia, 23249-0001, United States

  • Spokane VA Medical Center, Spokane, WA

    Spokane, Washington, 99205-6185, United States

  • VA Puget Sound Health Care System Seattle Division, Seattle, WA

    Seattle, Washington, 98108-1532, United States

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