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Smartphone camera aims to spot foot ulcers before they start

NCT ID NCT07300163

Knowledge-focused Sponsor: Diabetis JSC 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study will give 100 adults with diabetes a thermal camera that attaches to their smartphone to take daily pictures of their feet. The goal is to collect temperature data and see if hot spots can predict where foot ulcers might form. Participants will use the device at home for 6 to 9 months while continuing their usual care.

What this could mean

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

Active substance
FeetSee thermal camera device
What this could lead to
If successful, this could lead to a home monitoring tool that helps predict diabetic foot ulcers before they form.
What could go wrong
This is an early observational study with only 100 participants, so results may not apply to everyone. The device is not a replacement for standard care.

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 100 people

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

Started

Dec 2025

Expected to finish

May 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.

Who is studied

Adults (≥18 years) with type 1 or type 2 diabetes, a history of plantar diabetic foot ulcer(s) that have been fully healed for at least 6 weeks, clinical evidence of diabetic peripheral neuropathy, and at least one palpable foot pulse. This is a high-risk population for recurrent plantar diabetic foot ulceration, without active ulceration, active Charcot neuro-osteoarthropathy, severe peripheral arterial disease, or major lower-limb amputation (above metatarsophalangeal disarticulation).

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: * Males/females aged over 18 years. * Type 1 or type 2 diabetes. * History of plantar diabetic foot ulcer(s). * Foot ulcer healed for at least 6 weeks before entry into study, as determined by a specialist healthcare provider. * Presence of diabetic peripheral neuropathy defined by either of the following: * Inability to detect the monofilament (10g) applied at two foot sites, including the apex of the Hallux (ADA guidelines 2008 Diabetes Care 31(1)). * A Vibration Perception Threshold (VPT) \>20V, and/or by inability to detect application of the monofilament at the apex of the Hallux. * Presence of at least one palpable foot pulse. Exclusion Criteria: * Active foot ulceration. * Active Charcot neuro-osteoarthropathy. * Severe vascular disease (complete absence of any foot pulses). * Lower limb/foot amputation greater than metatarsophalangeal disarticulation. * Active malignancy, immunosuppressive disease. * Physical or mental condition(s) that limit the ability to follow instructions for the study, based on clinical judgment by the physician, such as inability to use the device without assistance. * Current participation in another clinical investigation of a medical device that is contraindicated for either study procedure/outcome.

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Conditions

The condition(s) this trial relates to.

Diabetic Foot diabetic neuropathy type 1 diabetes mellitus type 2 diabetes mellitus

As listed by the trial registrant

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

Diabetic foot ulcer

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    4 sites in 2 countries. 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

  • Blackpool Teaching Hospitals NHS Trust

    NOT_YET_RECRUITING

    Blackpool, United Kingdom

  • Lancashire Teaching Hospitals NHS Foundation Trust

    NOT_YET_RECRUITING

    Lancaster, United Kingdom

  • Manchester University NHS Foundation Trust (MFT)

    RECRUITING

    Manchester, United Kingdom

  • Vilnius University Hospital Santaros Klinikos

    RECRUITING

    Vilnius, Lithuania

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