Comprehensive Assistance and Resources for Effective Diabetic Foot Navigation

Part of paid clinical trials in Atlanta, Georgia.

Sponsor
Emory University
Study ID
NCT07223268
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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.
  • Standard of care — OTHER
    Standard of care for DFU.

Study Details

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)

Key Dates

Start date
Oct 7, 2025
Status verified
Oct 2025
Primary completion
Aug 31, 2030
Completion
Aug 31, 2030

Study Design

Enrollment
270 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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.

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

Locations (1)

FacilityCityStateZIPSite coordinators
Grady Memorial HospitalAtlantaGeorgia30303
Marcos Schechter, MD
[email protected]
404-251-8713
Maya Fayfman, MD
[email protected]
404-778-1664
Marcos Schechter, MD (PRINCIPAL_INVESTIGATOR)

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By research site
Grady Memorial Hospital· Atlanta, GA

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