Recruiting

CARE-D-Foot

Sponsor:

Emory University

Code:

NCT07223268

Conditions

Diabetic Foot Ulcer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

CARE-D-Foot-Nav

Standard of care

Study Details

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

Study ID

NCT07223268

Start date

Oct 7, 2025

Status verified date

Oct, 2025

Completion date

Aug, 2030

Anticipated

Primary completion date

Aug, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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 Criteria:

  • 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

Study Design

Enrollment

270 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: 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

experimental: 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.

Interventions

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.

Primary outcome measure

  • Effectiveness of CARE-D-Foot-Nav: 20-week wound healing with complete re-epithelialization of the wound [ Time Frame: Baseline, Week 20 (day 140 +/- 7 days) ]

Central Contacts and Locations

Central contacts

Marcos Schechter, MD

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

Maya Fayfman, MD

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

Locations

Grady Memorial Hospital

Recruiting

Atlanta, Georgia, United States, 30303

Contacts

Marcos Schechter, MD

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

Maya Fayfman, MD

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

Principal Investigator:

Marcos Schechter, MD

More Information

Sponsor

Emory University

Last update posted

Oct 31, 2025

Last verified

Oct, 2025

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Emory University on 2025-10-31.