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AI model aims to predict diabetes foot ulcers before they start

NCT ID NCT07307183

Knowledge-focused Sponsor: Sahlgrenska University Hospital 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study aims to create a prediction model using artificial intelligence and statistics to identify which people with diabetes are at risk of developing foot ulcers. Researchers will analyze health records and demographic data from 100,000 adults in Sweden. The goal is to improve early prevention and reduce serious complications like infections and amputations.

What this could mean

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

What this could lead to
If successful, this could lead to a reliable tool that helps doctors identify diabetes patients at high risk for foot ulcers early, enabling preventive care.
What could go wrong
This is an observational study using existing data, not a treatment trial. The models may not work perfectly in all populations or settings.

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 100,000 people

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

Started

Jan 2014

Expected to finish

Dec 2027

An estimate. End dates often move.

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.

Who is studied

The study population consists of all eligible adult patients receiving primary care within Region Västra Götaland (VGR). Data will be extracted from Assynja Whisp, the electronic health record system used by Närhälsan, the public primary care provider in VGR. The dataset includes information on all patients meeting the inclusion criteria who have been registered in the system during the study period. Extracted data comprise routinely collected clinical, diagnostic, and prescription information, enabling comprehensive population-based analyses

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: * Adult patients aged 18 years or older at the time of inclusion * Patients with a diagnosis of diabetes mellitus according to ICD-10 codes E10-E14, and/or * Patients who have been prescribed at least one diabetes-related medication after the age of 18 * Patients with relevant diagnoses and/or prescriptions recorded in the study data sources between 1 January 2014 and 30 June 2025 Exclusion Criteria: * Patients younger than 18 years of age at the time of diabetes diagnosis or prescription * Patients with no recorded diagnosis of diabetes (ICD-10 E10-E14) and no prescription of diabetes medication after the age of 18 * Patients with incomplete or missing key data required for model development or validation (e.g. missing outcome or essential covariates)

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Conditions

The condition(s) this trial relates to.

diabetes mellitus Diabetic Foot Foot Ulcer

As listed by the trial registrant

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

Diabete mellitus

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

  • Region Västra Götaland

    RECRUITING

    Jonsered, 43375, Sweden

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