Comprehensive assistance and navigation for diabetic foot ulcers
Official title: Comprehensive Assistance and Resources for Effective Diabetic Foot Navigation (CARE-D-Foot-Nav)
Run by Emory University · NCT07223268 · Data updated 2026-11-12
This program tests whether weekly support from a patient navigator helps people hospitalized with diabetic foot ulcers heal their wounds within 20 weeks.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 270 (estimated) |
| Sponsor | Emory University Academic / other |
| Locations | 1 site (Atlanta, Georgia) |
| Status | Recruiting |
| Started | October 7, 2025 |
| Main results expected | August 2030 |
| Study ends | August 2030 |
| Registry record updated | October 31, 2025 |
| Trial ID | NCT07223268 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults with diabetes who are hospitalized at the study site and have a full‑thickness diabetic foot ulcer or have undergone a single toe amputation, who can consent and plan to be discharged home, are ideal candidates.
✕Probably not a fit
Patients who undergo amputation of two or more toes, have severe foot infection/ischemia (SVS grade 4), are being discharged to acute or long‑term care facilities, cannot consent, or are enrolled in another clinical trial are unlikely to benefit from this program.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This randomized controlled trial will enroll 270 adults hospitalized with full‑thickness diabetic foot ulcers and randomize them to either usual care or the CARE-D-Foot-Nav intervention for 20 weeks after discharge. The intervention pairs participants with a certified diabetes educator who provides weekly personalized care coordination, diabetes education, transportation help, and connections to medical and social resources. The main outcome is wound healing at 20 weeks, and the study also uses mixed methods to measure program fidelity and acceptability and will perform a cost-effectiveness analysis. The program aims to address social determinants of health that hinder access to multidisciplinary DFU care, particularly in underserved populations.
Why it matters
Potential benefit: If successful, the program could increase wound healing rates, reduce amputations, and improve access to coordinated care for underserved patients with diabetic foot ulcers.
How similar studies have gone: Patient navigators have improved outcomes in other chronic diseases, but randomized trials of navigation for diabetic foot ulcers have not previously been done.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adults with diabetes admitted for any reason who have a full-thickness DFU (defined as a wound below the ankle through the dermis) or undergo a single toe amputation * History of prior amputations and DFUs of any severity Exclusion Criteria: * Adults unable to understand the nature and scope of the study, enrolled in another clinical trial, or planned for discharge to an acute or long-term care facility, * Patients who undergo amputation of two or more toes during hospitalization and/or have a Society for Vascular Surgery Wound, Ischemia, foot Infection grade 4
Where it's running
-
Grady Memorial Hospital
Atlanta, Georgia, United States 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
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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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.