Back to search results

CARE-D-FOOT-Nav Pilot for Diabetic Foot Ulcers

This pilot study is testing a program called Comprehensive Assistance and Resources for Effective Diabetic Foot Navigation (CARE-D-FOOT-Nav). This program uses a patient navigator to help people with diabetic foot ulcers (DFUs) get the best possible care. DFUs are serious foot sores that can lead to amputations. The study aims to see if this program can help more people heal their DFUs and avoid amputations. We are looking for about 25 adults, aged 18 or older, who have diabetes and are in the hospital for a DFU-related amputation of two or more toes. You must also be able to speak English. The study will measure how well the program is put into practice and if participants find it acceptable, over a period of up to 20 weeks.

Study design
This is an interventional pilot study with a planned enrollment of 25 participants. It is testing a patient navigator program.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The study measures outcomes for up to 20 weeks during program participation.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07143175

CARE-D-FOOT-Nav Pilot

Recruiting
NAAges 18+InterventionalSupportive care
Emory University
~25 participants
Updated 2025-08-27 on ClinicalTrials.gov
What's tested:Comprehensive Assistance and Resources for Effective Diabetic Foot Navigation

At a glance

Recruiting sites
1 of 4 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Proportion of the program components addressed
Measured over Up to 20 weeks during program participation
+1 more outcome measured

Conditions

Diabetic Foot Ulcer (DFU)

Explore related trials

Diabetic foot ulcer

Where it's being run

4 sites across 1 states
Georgia4

Study leadership

  • Marcos Schechter, MD · PRINCIPAL_INVESTIGATOR · Emory University

Who to contact

Marcos Schechter, MD
[email protected]
404-251-8713
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Proportion of the program components addressedUp to 20 weeks during program participation

    Researchers will measure the program fidelity by the proportion of the program components addressed by the navigators. Navigators will address 16 components during the weekly encounters and 22 components at every fourth encounter. Researchers will record all encounters and will listen to the recordings of encounters and count which components were or were not discussed (binary outcome, yes/no), and measure consistency across navigators.

  • Acceptability of the CARE-D-Foot-Nav interventionUp to 20 weeks during program participation

    Researchers will conduct focus group discussions and/or one-on-one interviews with the participants to understand the program's likes and dislikes. There is no measuring scale.