Comprehensive Assistance and Resources for Effective Diabetic Foot Navigation
NCT ID: NCT07223268
Last Updated: 2025-10-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
270 participants
INTERVENTIONAL
2025-10-07
2030-08-31
Brief Summary
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The study will further:
* Evaluate fidelity to and acceptability of the CARE-D-Foot-Nav program using mixed methods
* Perform a CARE-D-Foot-Nav cost-effectiveness analysis (CEA)
Detailed Description
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In this trial, 270 patients hospitalized with DFUs will be randomized to receive either usual care or participate in the CARE-D-Foot-Nav program for 20 weeks after hospital discharge. Participants in the intervention group will receive weekly support from a certified diabetes educator acting as a patient navigator, who will provide personalized care coordination, diabetes education, transportation assistance, and help connecting patients to medical and social resources.
Navigators have proven effective in improving outcomes for other chronic diseases by overcoming healthcare system and patient-level barriers, but no prior randomized trials have tested their impact on DFU care specifically. This study aims to fill that gap by evaluating whether the CARE-D-Foot-Nav program improves DFU healing rates, enhances patient engagement, and can be implemented cost-effectively. The intervention is designed to be scalable and focused on reducing healthcare disparities to help curb the diabetes-related amputation epidemic.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Standard of Care
Following discharge, the team will conduct research retention phone calls at 4, 8, 12, 16, and 20 weeks to review resource utilization over the past month.
Participants will have access to hospital and community resources available to all patients treated within the healthcare system.
Other resources may include, but are not limited to, social worker assistance with transportation, diabetes education (with referral by medical provider), nutritional support through Grady's "Food as Medicine Program", and interpreter services
Standard of care
Standard of care for DFU.
CARE-D-Foot-Nav
Participants in this arm will be assigned a dedicated DFU patient navigator The navigators will conduct 30-to 60-minute encounters, either by phone or in person, at least once a week during the 20-week program.
Participants can call the navigator with DFU-related concerns during the navigator's working hours.
CARE-D-Foot-Nav
CARE-D-Foot-Nav is a diabetes educator who will serve as a dedicated Diabetic Foot Ulcer (DFU) patient navigator.
The navigator will assist the subjects with diabetic foot ulcer care, including: Glycemic control, Wound management, Infection management, and peripheral artery disease (PAD) management.
Apart from that, the navigator will also provide tools to improve access to DFU care and emotional support, like: Outpatient care coordination, Transportation assistance, Language-concordant care, Peer support, Support if amputations are recommended, and Spiritual Support.
Navigator will also assess the participants and screen for Depression, tobacco use, food insecurity, alcohol use, financial resource strain, and housing instability.
Interventions
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CARE-D-Foot-Nav
CARE-D-Foot-Nav is a diabetes educator who will serve as a dedicated Diabetic Foot Ulcer (DFU) patient navigator.
The navigator will assist the subjects with diabetic foot ulcer care, including: Glycemic control, Wound management, Infection management, and peripheral artery disease (PAD) management.
Apart from that, the navigator will also provide tools to improve access to DFU care and emotional support, like: Outpatient care coordination, Transportation assistance, Language-concordant care, Peer support, Support if amputations are recommended, and Spiritual Support.
Navigator will also assess the participants and screen for Depression, tobacco use, food insecurity, alcohol use, financial resource strain, and housing instability.
Standard of care
Standard of care for DFU.
Eligibility Criteria
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Inclusion Criteria
* History of prior amputations and DFUs of any severity
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NIH
Emory University
OTHER
Responsible Party
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Marcos C. Schechter
Associate Professor
Principal Investigators
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Marcos Schechter, MD
Role: PRINCIPAL_INVESTIGATOR
Emory University
Locations
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Grady Memorial Hospital
Atlanta, Georgia, United States
Countries
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Central Contacts
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Facility Contacts
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Marcos Schechter, MD
Role: primary
Maya Fayfman, MD
Role: backup
Other Identifiers
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STUDY00008140
Identifier Type: -
Identifier Source: org_study_id