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A personal guide through the healthcare maze: could a navigator save limbs from diabetes?

NCT ID NCT07143175

Disease control Sponsor: Emory University 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 02, 2026 · Last updated Sep 03, 2026 · Updated 1 time

Summary

This pilot study tests a program called CARE-D-Foot-Nav, where a trained navigator, such as a diabetes educator, helps people with diabetic foot ulcers access specialized care. Participants receive weekly check-ins by phone or in person for 20 weeks, plus practical help like transportation and wound supplies. The goal is to see if the program is practical and acceptable to patients, and whether it can improve wound healing and reduce the risk of amputation.

What this could mean

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

Active substance
A patient navigator program where diabetes educators, dietitians, or medical assistants provide weekly support, resources, transportation help, and wound care supplies to people with diabetic foot ulcers.
What this could lead to
If it works, this program could offer a practical, cost-effective way to help more people with diabetic foot ulcers heal and avoid amputations.
What could go wrong
This is a small pilot study focused on feasibility and acceptability, not proof of healing. The program may not be widely adopted or may not improve outcomes in larger, more diverse groups.

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

About 25 people

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

Started

Aug 2025

Expected to finish

Jul 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.

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: * Adults (≥18 years old) with diabetes admitted to the hospital for any reason who undergo a DFU-related amputation of 2 or more digits (including minor and major amputations) * English-speaking patients (available patient navigators are English-speaking). Exclusion Criteria: * Patients who are unable to understand the nature and scope of the study, * Enrolled in another clinical trial, * Planned discharge to an acute or long-term care facility, * Planning to receive outpatient DFU care outside of Grady.

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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.

Diabetic foot ulcer (DFU)

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. 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

  • Emory Decatur Hospital

    NOT_YET_RECRUITING

    Decatur, Georgia, 30033, United States

  • Emory University Hospital (EUH)

    NOT_YET_RECRUITING

    Atlanta, Georgia, 30322, United States

  • Emory University Hospital Midtown

    NOT_YET_RECRUITING

    Atlanta, Georgia, 30308, United States

  • Grady Memorial Hospital

    RECRUITING

    Atlanta, Georgia, 30303, United States

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