Comprehensive Diabetic Foot Navigation (CARE-D-Foot-Nav) Pilot
Official title: Comprehensive Assistance and Resources for Effective Diabetic Foot Navigation (CARE-D-Foot-Nav), a Single-arm Pilot Study
Run by Emory University · NCT07143175 · Data updated 2026-11-12
This pilot will test whether a patient navigator program helps hospitalized adults with diabetic foot ulcers who had foot amputations get coordinated care and heal better.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 25 (estimated) |
| Sponsor | Emory University Academic / other |
| Locations | 4 sites (Atlanta, Georgia and 3 other locations) |
| Status | Recruiting |
| Started | August 5, 2025 |
| Main results expected | July 2027 |
| Study ends | July 2027 |
| Registry record updated | September 2, 2026 |
| Trial ID | NCT07143175 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (≥18 years) with diabetes who are hospitalized at participating Emory/Grady hospitals, underwent a DFU-related amputation of two or more digits, and speak English are the ideal candidates.
✕Probably not a fit
Non–English-speaking patients, those discharged to acute or long-term care facilities, patients planning outpatient DFU care outside Grady, or those unable to understand the program are unlikely to benefit from this intervention.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
CARE-D-Foot-Nav is a pilot interventional program that assigns each participant a dedicated diabetic foot ulcer (DFU) patient navigator (a diabetes educator, registered dietitian, or medical assistant) who provides weekly 30–60 minute phone or in-person contacts over a 20-week period. Navigators help with care logistics, connect patients to resources, and promote engagement with multidisciplinary wound, vascular, infection, and diabetes care teams. The trial enrolls adults with diabetes hospitalized at participating Emory/Grady hospitals who undergo DFU-related amputation of two or more digits and who speak English. Outcomes focus on healing-related metrics and the feasibility of implementing navigator-led support in this high-risk, often underserved population.
Why it matters
Potential benefit: If successful, this program could improve DFU healing, reduce repeat or higher-level amputations, and increase access to coordinated multidisciplinary care for high-risk patients.
How similar studies have gone: Patient navigator programs have improved some diabetes outcomes in prior work, but navigator-led interventions specifically targeting DFU healing are largely untested.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
-
Grady Memorial Hospital
Atlanta, Georgia, United States Recruiting -
Emory University Hospital Midtown
Atlanta, Georgia, United States Not yet recruiting -
Emory University Hospital (EUH)
Atlanta, Georgia, United States Not yet recruiting -
Emory Decatur Hospital
Decatur, Georgia, United States Not yet recruiting
Study contacts
- Principal investigator: Marcos Schechter, MD — Emory University
- Study coordinator: Marcos Schechter, MD
- Email: marcos.coutinho.schechter@emory.edu
- Phone: 404-251-8713
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.