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New care model aims to save limbs for rural diabetes patients

NCT ID NCT05203471

Disease control Sponsor: University of Wisconsin, Madison Source: ClinicalTrials.gov ↗

What the study statuses mean

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 a new way of coordinating care for rural patients with diabetic foot ulcers, who are at higher risk of major leg amputation. The model connects rural clinics with specialists to ensure patients receive timely, guideline-based treatment. Researchers compared outcomes for 131 patients receiving this integrated care to historical data, focusing on reducing above-ankle amputations. The goal was to gather evidence for a larger statewide trial.

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

131 people

The number who actually took part.

Started

Feb 2023

Finished

Jun 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 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: * Healthcare worker inclusion criteria: * Willing to provide informed consent * Willing to comply with study procedures * Rural providers (primary care physicians at the UW Health Belleville Family Medicine Clinic, diabetes and wound care specialists at Sauk Prairie Healthcare Diabetes and Wound Care Clinic) and schedulers placing referrals. * Employed at a participating clinic * For rural providers, confirm understanding that they will retain clinical discretion to deviate from the integrated care model if they think it would best serve the patient. * Available for the duration of the study * Patient inclusion criteria: * Able and willing to provide informed consent. * Willing to comply with study procedures and be available for the duration of the study. * 18 years of age and older. * Patient with either type 1 or type 2 diabetes at a participating rural clinic. * Develops diabetic foot ulcer during enrollment period. Exclusion Criteria: * Healthcare worker exclusion criteria: * Insufficient overlap in work schedules between rural providers and scheduler based on clinic manager determination. * Patient exclusion criteria: * receiving palliative care such that referral to urban centers for aggressive limb salvage would be inappropriate, as assessed by patient rural provider * insurance does not cover referral to the University of Wisconsin's specialty clinics * Not suitable for study participation due to other reasons at the discretion of the investigators.

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Conditions

The condition(s) this trial relates to.

Diabetic Foot

As listed by the trial registrant

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

Amputation Diabetic foot Diabetic ulcer of left foot Diabetic ulcer of right foot

Contacts and locations

Locations

  • University of Wisconsin-Madison

    Madison, Wisconsin, 53705, United States

More trials for these conditions

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