Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT07223268

Comprehensive Assistance and Resources for Effective Diabetic Foot Navigation

Led by Emory University · Updated on 2025-10-31

270

Participants Needed

1

Research Sites

251 weeks

Total Duration

On this page

Sponsors

E

Emory University

Lead Sponsor

N

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

Collaborating Sponsor

AI-Summary

What this Trial Is About

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 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)

CONDITIONS

Official Title

Comprehensive Assistance and Resources for Effective Diabetic Foot Navigation

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults with diabetes admitted for any reason who have a full-thickness diabetic foot ulcer below the ankle or have undergone a single toe amputation
  • History of prior amputations and diabetic foot ulcers of any severity
Not Eligible

You will not qualify if you...

  • Adults unable to understand the nature and scope of the study
  • Currently enrolled in another clinical trial
  • Planned for discharge to an acute or long-term care facility
  • Undergoing amputation of two or more toes during hospitalization
  • Have a Society for Vascular Surgery Wound, Ischemia, Foot Infection grade 4

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Grady Memorial Hospital

Atlanta, Georgia, United States, 30303

Actively Recruiting

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Research Team

M

Marcos Schechter, MD

CONTACT

M

Maya Fayfman, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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