Status:

RECRUITING

Comprehensive Assistance and Resources for Effective Diabetic Foot Navigation

Lead Sponsor:

Emory University

Collaborating Sponsors:

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Conditions:

Diabetic Foot Ulcer

Eligibility:

All Genders

18+ years

Phase:

NA

Brief Summary

The purpose of this interventional study is to assess the effectiveness of CARE-D-Foot, a patient navigator intervention, as compared to usual care, on 20-week diabetic foot ulcer healing. The study ...

Detailed Description

The CARE-D-Foot-Nav (Comprehensive Assistance and Resources for Effective Diabetic Foot Navigation) study is a randomized controlled trial testing whether a patient navigator-led intervention can impr...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

October 7 2025

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

August 1 2030

Estimated Enrollment :

270 Patients enrolled

Trial Details

Trial ID

NCT07223268

Start Date

October 7 2025

End Date

August 1 2030

Last Update

October 31 2025

Active Locations (1)

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Page 1 of 1 (1 locations)

1

Grady Memorial Hospital

Atlanta, Georgia, United States, 30303