CARE-D-FOOT-Nav Pilot

NCT07143175 | Recruiting

• 1 other identifier: STUDY00008869
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 4

Brief Summary

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). 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.

Conditions

Diabetic Foot Ulcer (DFU)

Keywords

Assistance for Effective Diabetic Foot Navigation; Navigators; Wound care; Wound healing

Outcome Measures

Primary Outcomes (2)

• Proportion of the program components addressed

  Researchers will measure the program fidelity by the proportion of the program components addressed by the navigators. Navigators will address 16 components during the weekly encounters and 22 components at every fourth encounter. Researchers will record all encounters and will listen to the recordings of encounters and count which components were or were not discussed (binary outcome, yes/no), and measure consistency across navigators.

  Up to 20 weeks during program participation

• Acceptability of the CARE-D-Foot-Nav intervention

  Researchers will conduct focus group discussions and/or one-on-one interviews with the participants to understand the program's likes and dislikes. There is no measuring scale.

  Up to 20 weeks during program participation

Secondary Outcomes (20)

• Number of participants with wound healing with complete re-epithelialization of the wound.

  Baseline and week 20 (day 140 +/- 7 days)

• Number of participants with confirmed wound healing

  Baseline and week 22

• DFU care clinic attendance

  At 14 days and 30 days after hospital discharge

• Wound area reduction

  Baseline and week 20

• Major amputations

  After hospital discharge (up to 20 weeks)

Other Outcomes (1)

• Costs and resource utilization

  After hospital discharge (up to 20 weeks)

Study Arms (1)

Intervention Group

EXPERIMENTAL

Participants will be assigned a dedicated DFU patient navigator.

Other: Comprehensive Assistance and Resources for Effective Diabetic Foot Navigation

Interventions

Comprehensive Assistance and Resources for Effective Diabetic Foot Navigation OTHER

The CARE-D-FOOT-Nav (Comprehensive Assistance and Resources for Effective Diabetic Foot Navigation) program is a patient navigator intervention that aims to increase access to guideline-concordant multidisciplinary DFU care to improve DFU healing. 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. Based on community input, navigators will conduct 30-to 60-minute encounters, either by phone or in person, at least once a week during the 20-week program. Additional contact may be warranted to coordinate appointments and transportation. Participants can call the navigator with DFU-related concerns at any time during the navigator's working hours. The overarching goal of the navigator is to help patients access the four key pillars of DFU care, thereby optimizing the chances of DFU healing.

Also known as: CARE-D-Foot-Nav, Diabetic Foot Navigator

Intervention Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Emory University: lead

Study Sites (4)

Grady Memorial Hospital

Atlanta, Georgia, 30303, United States

RECRUITING

Emory University Hospital Midtown

Atlanta, Georgia, 30308, United States

NOT YET RECRUITING

Emory University Hospital (EUH)

Atlanta, Georgia, 30322, United States

NOT YET RECRUITING

Emory Decatur Hospital

Decatur, Georgia, 30033, United States

NOT YET RECRUITING

MeSH Terms

Conditions

Diabetic Foot

Interventions

Health Resources

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies

Intervention Hierarchy (Ancestors)

Health Planning; Health Care Economics and Organizations; Delivery of Health Care; Health Care Quality, Access, and Evaluation

Study Officials

• Marcos Schechter, MD

  Emory University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marcos Schechter, MD

CONTACT

404-251-8713; marcos.coutinho.schechter@emory.edu

Maya Fayfman, MD

CONTACT

404-778-1664; maya.fayfman@emory.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Single-arm prospective study.

Study Record Dates

• First Submitted: August 8, 2025
• First Posted: August 27, 2025
• Study Start: August 5, 2025
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: August 27, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)