Patient navigator support for adults with diabetic foot ulcers
Tests a patient navigator program in adults with diabetic foot ulcers.
Key facts
- Who runs it
- Emory University
- Where
- Atlanta and Decatur, United StatesSee the 4 sites
- Trial code
- Registry title
- CARE-D-FOOT-Nav Pilot
- Status
- Recruiting
- People taking part
- 25 people, planned
- Started
- 5 Aug 2025
- Expected to end
- Jul 2027
- Type of study
- Interventional
- Treatments tested
- Comprehensive Assistance and Resources for Effective Diabetic Foot Navigation
- Record updated
- 2 September 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with diabetes in hospital who have an amputation of 2 or more toes or more because of a diabetic foot ulcer (a foot sore). They get a personal helper (navigator) for 20 weeks.
- Age
- 18 years and older
- Sex
- All sexes
- Disease stage
- Diabetic foot ulcer leading to an amputation of 2 or more digits, minor or major, during a hospital stay for any reason.
- Earlier treatment
- Must have an amputation of 2 or more digits related to a diabetic foot ulcer during the hospital stay.
Main reasons for not taking part
- Not able to understand what the study is about
- Taking part in another clinical trial
- Planned to leave hospital for an acute or long-term care facility
- Planning to get outpatient foot ulcer care outside of Grady
- Not English-speaking
The registry criteria, word for word
Show all 6 criteriaShow less
Who can take part
- 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)
Who cannot take part
- 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 in United States
- Emory University Hospital (EUH)Atlanta, United StatesContact: Marcos Schechter, MDNot yet recruiting
- Emory University Hospital MidtownAtlanta, United StatesContact: Marcos Schechter, MDNot yet recruiting
- Grady Memorial HospitalAtlanta, United StatesContact: Marcos Schechter, MDTaking people
- Emory Decatur HospitalDecatur, United StatesContact: Marcos Schechter, MDNot yet recruiting
About the trial
What the trial wants to find out
This pilot study aims to examine the implementation of a patient navigator intervention called Comprehensive Assistance and Resources for Effective Diabetic Foot Navigation (CARE-D-Foot-Nav).
Read full original descriptionShow less
Up to one-third of the 37 million people living with diabetes in the United States will experience a diabetic foot ulcer in their lifetime, and non-healing diabetic foot ulcers are the reason for almost all 100,000 diabetes-related amputations that occur annually in this country. Multidisciplinary diabetic foot care improves ulcer healing; however, people face challenges in navigating the healthcare system to access high-quality, multidisciplinary care, and amputations are on the rise.
Participants enrolled in Care-D-Foot-Nav will be assigned to a diabetes educator and/or registered dietitian, and/or medical assistant who will serve as a dedicated DFU patient navigator. The navigators will conduct 30-60-minute encounters by phone or in person at least once a week during the 20-week program. The navigator will provide additional resources depending on the unique needs and circumstances of the participant. In addition, participants may receive transportation assistance and wound care supplies if needed.
This pilot study aims to evaluate the program's fidelity and acceptability. The findings of this study may provide a new and cost-effective approach to managing this devastating disease.
The group in the trial
- Intervention GroupTreatment being tested
Participants will be assigned a dedicated DFU patient navigator.
Treatment: Comprehensive Assistance and Resources for Effective Diabetic Foot Navigation
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Comprehensive Assistance and Resources for Effective Diabetic Foot Navigation (CARE-D-Foot-Nav), a Single-arm Pilot Study
- Plain-language title
- Patient navigator support for adults with diabetic foot ulcersGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 15 November 2026.
- Record updated
- 2 September 2026