Amputation, Diabetic Foot, Diabetic Ulcer of Left Foot, Diabetic Ulcer of Right Foot
Conditions
Keywords
Multidisciplinary care, Integrated care, Rural disparities, Recruitment, Retention
Brief summary
This project directly addresses the escalating national rate of major (above-ankle) amputations due to diabetic foot ulcers; it focuses on rural patients, who face 37% higher odds of major amputation compared to their urban counterparts. The project pilots the first integrated care model adapted to rural settings, an approach that has reduced major amputations in urban settings by approximately 40%. Pilot data will be used to improve recruitment and retention strategies and provide preliminary evidence of efficacy needed to conduct a robust, statewide efficacy trial.
Interventions
The investigators are piloting an integrated care model for rural patients with diabetic foot ulcers. The model uses two tools to promote collaboration between providers: a care algorithm and a referral checklist. The care algorithm will be used by rural primary care providers to guide integrated care addressing glycemic control, vascular disease, wound care, and infection. The referral checklist will be used by rural schedulers who place referrals to urban specialists. It prompts schedulers to fax appropriate supporting documents (e.g. notes, labs, vascular testing results) with the referral request.
Sponsors
University of Wisconsin, Madison
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Intervention model description
This is an adaptive study design where recruitment and retention protocols are modified to improve involvement of rural study participants over three waves. Actively enrolled participants receive/ provide care for diabetic foot ulcers using a care algorithm and referral checklist. Results are compared to historical controls.
Eligibility
Sex/Gender
ALL
Age
18 Years to 89 Years
Healthy volunteers
No
Inclusion criteria
* Healthcare worker inclusion criteria: * Willing to provide informed consent * Willing to comply with study procedures * Rural providers (primary care physicians at the UW Health Belleville Family Medicine Clinic, diabetes and wound care specialists at Sauk Prairie Healthcare Diabetes and Wound Care Clinic) and schedulers placing referrals. * Employed at a participating clinic * For rural providers, confirm understanding that they will retain clinical discretion to deviate from the integrated care model if they think it would best serve the patient. * Available for the duration of the study * Patient inclusion criteria: * Able and willing to provide informed consent. * Willing to comply with study procedures and be available for the duration of the study. * 18 years of age and older. * Patient with either type 1 or type 2 diabetes at a participating rural clinic. * Develops diabetic foot ulcer during enrollment period.
Exclusion criteria
* Healthcare worker
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Patients Receiving Guideline-concordant Vascular and Infectious Disease Care Processes | up to 3 months | (proportion of integrated care patients receiving guideline-concordant vascular and infectious disease care within 3 months of their enrollment) minus (the proportion of historical patients receiving guideline-concordant vascular and infectious disease care within 3 months of participant enrollment) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Patients Undergoing Amputation | up to 3 months | (proportion of integrated care patients undergoing amputation within 3 months of their enrollment) minus (proportion of historical patients undergoing amputation within 3 months of their enrollment), where amputation is defined as major (above the ankle) or minor amputation (below the ankle) of the ipsilateral lower extremity to the index ulcer. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORMeghan B Brennan, MD
University of Wisconsin, Madison
Participant flow
Recruitment details
Patient Participants were prospectively enrolled for Integrated Care from 3 rural Wisconsin clinics and on study from February 2023 to June 2025. Historical Controls were identified from retrospective chart review. Healthcare workers (rural providers and clinic schedulers) were enrolled to make them aware of the study but there was no data collected for them.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 64.05 years |
| Area Deprivation Index (ADI) | 4.2 units on a scale |
| Baseline Medications ACE inhibitor (yes) | 10 Participants |
| Baseline Medications Angiotensin II receptor blocker (yes) | 12 Participants |
| Baseline Medications Anticoagulant (yes) | 61 Participants |
| Baseline Medications Statin (yes) | 23 Participants |
| Body Mass Index (BMI) | 35.8 kilograms per meter squared |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 115 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 12 Participants |
| Preexisting Conditions Charcot arthropathy (yes) | 6 Participants |
| Preexisting Conditions Coronary artery disease (yes) | 12 Participants |
| Preexisting Conditions Hyperlipidemia (yes) | 85 Participants |
| Preexisting Conditions Hypertension (yes) | 21 Participants |
| Preexisting Conditions Peripheral neuropathy (yes) | 24 Participants |
| Preexisting Conditions Stroke/TIA (yes) | 11 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 12 Participants |
| Race (NIH/OMB) White | 10 Participants |
| Region of Enrollment United States | 131 participants |
| Sex: Female, Male Female | 45 Participants |
| Sex: Female, Male Male | 25 Participants |
| Tobacco Status Current User | 13 Participants |
| Tobacco Status Former User | 43 Participants |
| Tobacco Status Never User | 35 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 3 / 81 | 1 / 27 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 4 / 27 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 2 / 27 | 0 / 0 |
Outcome results
None listed