Comprehensive Assistance and Resources for Effective Diabetic Foot Navigation

NCT07223268 | Recruiting

• 2 other identifiers: STUDY000081401R01DK139326-01A1
• Study Type: interventional
• Target: 270
• Locations: 1 country
• Sites: 1

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 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

Diabetic Foot Ulcer

Keywords

Comprehensive Assistance and Resources for Effective Diabetic Foot Navigation; Wound care; Wound healing

Outcome Measures

Primary Outcomes (1)

• Effectiveness of CARE-D-Foot-Nav: 20-week wound healing with complete re-epithelialization of the wound

  Pictures will be taken at baseline and week 20 and compared by two different reviewers. The number of participants with complete wound healing will be reported.

  Baseline, Week 20 (day 140 +/- 7 days)

Secondary Outcomes (20)

• Number of participants with confirmed wound healing

  Baseline, week 22

• DFU care clinic attendance

  Within 14 and 30 days post hospital discharge

• Wound area reduction

  Baseline, Week 20

• Major amputation

  Baseline, Week 20

• Number of deaths

  Baseline, Week 20

Study Arms (2)

Standard of Care

ACTIVE COMPARATOR

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

Other: Standard of care

CARE-D-Foot-Nav

EXPERIMENTAL

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.

Other: CARE-D-Foot-Nav

Interventions

CARE-D-Foot-Nav OTHER

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.

CARE-D-Foot-Nav

Standard of care OTHER

Standard of care for DFU.

Standard of Care

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Emory University: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

Grady Memorial Hospital

Atlanta, Georgia, 30303, United States

RECRUITING

Related Publications (1)

• Schechter MC, Rhodes EC, Shao H, Ahmed S, Colquitt K, Chaudhry NY, Dunlop AL, Flores J, Garcia-Toca M, Javia V, Kalokhe AS, Manoj A, Meadows C, Meriwether N, Sales JM, Soleimanmanesh N, Santamarina G, Smith-Bankhead NK, Umpierrez G, Ramos CR, Watson E, Peng L, Fayfman M. A randomized controlled trial of patient navigators for post-hospital discharge diabetic foot ulcer care: the Comprehensive Assistance and Resources for Effective Diabetic Foot Navigation (CARE-D-Foot-Nav) study protocol. medRxiv [Preprint]. 2025 Nov 27:2025.11.25.25340976. doi: 10.1101/2025.11.25.25340976.

  PMID: 41358308 DERIVED

MeSH Terms

Conditions

Diabetic Foot

Interventions

Standard of Care

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)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; 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: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: October 23, 2025
• First Posted: October 31, 2025
• Study Start: October 7, 2025
• Primary Completion (Estimated): August 1, 2030
• Study Completion (Estimated): August 1, 2030
• Last Updated: October 31, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Start: January 1, 2031. End: life of the Emory Dataverse Repository
• Access Criteria: Requests via email

Locations

US (1)