Comprehensive Assistance and Resources for Effective Diabetic Foot Navigation
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: CARE-D-Foot-Nav, Standard of care.
- Who it may be relevant to
- Registry conditions: Diabetic Foot Ulcer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Comprehensive Assistance and Resources for Effective Diabetic Foot Navigation (CARE-D-Foot-Nav)
Overview
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)
Detailed description
The CARE-D-Foot-Nav (Comprehensive Assistance and Resources for Effective Diabetic Foot Navigation) study is a randomized controlled trial testing whether a patient navigator-led intervention can improve healing outcomes for patients hospitalized with diabetic foot ulcers (DFUs). DFUs are a serious complication of diabetes that contribute to over 100,000 amputations annually in the U.S. and account for a significant portion of diabetes-related healthcare costs. Healing requires complex, multidisciplinary care focused on glycemic control, wound management, vascular disease treatment, and infection therapy. However, many patients, especially underserved populations such as non-Hispanic Black and Hispanic individuals, face barriers related to social determinants of health that hinder access to this care.
In this trial, 270 patients hospitalized with DFUs will be randomized to receive either usual care or participate in the CARE-D-Foot-Nav program for 20 weeks after hospital discharge. Participants in the intervention group will receive weekly support from a certified diabetes educator acting as a patient navigator, who will provide personalized care coordination, diabetes education, transportation assistance, and help connecting patients to medical and social resources.
Navigators have proven effective in improving outcomes for other chronic diseases by overcoming healthcare system and patient-level barriers, but no prior randomized trials have tested their impact on DFU care specifically. This study aims to fill that gap by evaluating whether the CARE-D-Foot-Nav program improves DFU healing rates, enhances patient engagement, and can be implemented cost-effectively. The intervention is designed to be scalable and focused on reducing healthcare disparities to help curb the diabetes-related amputation epidemic.
Interventions
- Other 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, - Other Standard of care
Standard of care for DFU.
Primary outcome measures
- 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)]
Secondary outcome measures (12)
- Number of participants with confirmed wound healing [Time frame: Baseline, week 22]
- DFU care clinic attendance [Time frame: Within 14 and 30 days post hospital discharge]
- Wound area reduction [Time frame: Baseline, Week 20]
- Major amputation [Time frame: Baseline, Week 20]
- Number of deaths [Time frame: Baseline, Week 20]
- EuroQol five-dimensional (EQ-5D) score [Time frame: Baseline, Week 20]
- Glycemic control: Change in HbA1c [Time frame: Baseline, Week 20]
- Perceived social support: Interpersonal Support Evaluation List-12 [Time frame: Baseline, Week 20]
- Medical mistrust: Change in the Trust in Physicians Scale [Time frame: Baseline, Week 20]
- Tobacco cessation [Time frame: Baseline, Week 20]
- Acute care utilization [Time frame: After hospital discharge (up to 20 weeks)]
- Services accessed [Time frame: Baseline, Week 20]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Grady Memorial Hospital — Atlanta
Publications
- 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 Assi PMID 41358308
Identifiers
NCT: NCT07223268 · STUDY00008140 · 1R01DK139326-01A1