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| ID | Type | Description | Link |
|---|---|---|---|
| R01DK132569-01 | U.S. NIH Grant/Contract | View source | |
| Protocol Version 2/6/2025 | Other Identifier | UW Madison | |
| SMPH/MEDICINE/INFECT DIS | Other Identifier | UW Madison |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Historical controls | No Intervention | Patients with diabetic foot ulcers cared for by a primary care provider participating in the study prior to launching the integrated care intervention. | |
| Integrated care | Active Comparator | Patients with diabetic foot ulcers cared for by a primary care provider participating in the study after launching the integrated care intervention. Only patients who provide informed consent and enroll in the study will be treated with our integrated care model. All other patients with a participating primary care provider will be treated using a standard care model and will not be considered study participants. |
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| Healthcare Worker | No Intervention | Healthcare worker employed in a clinic that agreed to take part in this study and provides care for patients with diabetic foot ulcers. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| integrated care model | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Patients Receiving Guideline-concordant Vascular and Infectious Disease Care Processes | (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) | up to 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Patients Undergoing Amputation | (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. | up to 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Recruitment Rate | Number of patients who enrolled in the study divided by the number of patients the study team attempted to contact for study recruitment | up to 3 months |
| Patient Retention Rate |
Inclusion Criteria:
Healthcare worker inclusion criteria:
Patient inclusion criteria:
Exclusion Criteria:
Healthcare worker exclusion criteria:
Patient exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Meghan B Brennan, MD | University of Wisconsin, Madison | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Wisconsin-Madison | Madison | Wisconsin | 53705 | United States |
Individual participant data collected during the study, after de-identification will be available to researchers for independent verification of study outcomes or to conduct subsequent clinical research, whose proposed use of the data has been approved by an independent review committee identified for this purpose.
Beginning 9 months after publication of primary outcomes and ending 5 years after that date.
Proposals should be directed to the PI, Dr. Meghan Brennan (mbbrennan@medicine.wisc.edu). If approved after review by regulatory counsel, requestors will enter into a formal data sharing agreement. Data will be shared via encrypted single-user file transmission protocol.
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Historical Controls | Patients with diabetic foot ulcers cared for by a primary care provider participating in the study prior to launching the integrated care intervention. |
| FG001 | Integrated Care |
| Title | Milestones | Reasons Not Completed | ||||
|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 13, 2025 |
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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.
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Number of patients who completed the 3-month follow-up telephone call divided by the number of patients who enrolled in the study
| up to 3 months |
Patients with diabetic foot ulcers cared for by a primary care provider participating in the study after launching the integrated care intervention. Only patients who provide informed consent and enroll in the study will be treated with our integrated care model. All other patients with a participating primary care provider will be treated using a standard care model and will not be considered study participants.
integrated care model: 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.
| FG002 | Healthcare Workers | Healthcare worker employed in a clinic that agreed to take part in this study and provides care for patients with diabetic foot ulcers. |
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| COMPLETED |
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| NOT COMPLETED |
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Study relevant baseline data not collected from Healthcare Workers per protocol.
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| ID | Title | Description |
|---|---|---|
| BG000 | Historical Controls | Patients with diabetic foot ulcers cared for by a primary care provider participating in the study prior to launching the integrated care intervention. |
| BG001 | Integrated Care | Patients with diabetic foot ulcers cared for by a primary care provider participating in the study after launching the integrated care intervention. Only patients who provide informed consent and enroll in the study will be treated with our integrated care model. All other patients with a participating primary care provider will be treated using a standard care model and will not be considered study participants. |
| BG002 | Healthcare Workers | Healthcare worker employed in a clinic that agreed to take part in this study and provides care for patients with diabetic foot ulcers. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Healthcare Workers were not the target population for data collection. Study relevant baseline data not collected from Healthcare Workers per protocol. | Mean | Full Range | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Area Deprivation Index (ADI) | ADI is a measure of the socioeconomics of neighborhoods. It is scored from 1 (least disadvantaged) to 10 (most disadvantaged). | Healthcare Workers were not the target population for data collection. Study relevant baseline data not collected from them per protocol. | Mean | Full Range | units on a scale |
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| Body Mass Index (BMI) | BMI is a measure of body fat calculated using weight in kilograms divided by height in meters squared. | Healthcare Workers were not the target population for data collection. Study relevant baseline data not collected from them per protocol. | Mean | Full Range | kilograms per meter squared |
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| Tobacco Status | Healthcare Workers were not the target population for data collection. Study relevant baseline data not collected from them per protocol. | Count of Participants | Participants |
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| Preexisting Conditions | Healthcare Workers were not the target population for data collection. Study relevant baseline data not collected from them per protocol. | Count of Participants | Participants |
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| Baseline Medications | Healthcare Workers were not the target population for data collection. Study relevant baseline data not collected from them per protocol. | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Proportion of Patients Receiving Guideline-concordant Vascular and Infectious Disease Care Processes | (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) | Posted | Count of Participants | Participants | up to 3 months |
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| Secondary | Proportion of Patients Undergoing Amputation | (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. | Posted | Count of Participants | Participants | up to 3 months |
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| Other Pre-specified | Patient Recruitment Rate | Number of patients who enrolled in the study divided by the number of patients the study team attempted to contact for study recruitment | Number of participants analyzed here represents the number of people approached to participate | Posted | Count of Participants | Participants | up to 3 months |
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| Other Pre-specified | Patient Retention Rate | Number of patients who completed the 3-month follow-up telephone call divided by the number of patients who enrolled in the study | Posted | Count of Participants | Participants | up to 3 months |
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up to 3 months on study
Historical Controls were only assessed for all-cause mortality and not AE or SAE data. Adverse events data (all cause mortality, SAEs, AEs) was monitored for patient participants only. Healthcare workers were not a population at risk and were not assessed for adverse events.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Historical Controls | Patients with diabetic foot ulcers cared for by a primary care provider participating in the study prior to launching the integrated care intervention. | 3 | 81 | 0 | 0 | 0 | 0 |
| EG001 | Integrated Care | Patients with diabetic foot ulcers cared for by a primary care provider participating in the study after launching the integrated care intervention. Only patients who provide informed consent and enroll in the study will be treated with our integrated care model. All other patients with a participating primary care provider will be treated using a standard care model and will not be considered study participants. | 1 | 27 | 2 | 27 | 4 | 27 |
| EG002 | Healthcare Workers | Healthcare worker employed in a clinic that agreed to take part in this study and provides care for patients with diabetic foot ulcers. | 0 | 0 | 0 | 0 | 0 | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| deep space abscess | Injury, poisoning and procedural complications | Non-systematic Assessment | Hospitalization with surgical I&D deep space abscess, unrelated to study intervention |
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| Myocardial Infarction | Cardiac disorders | Non-systematic Assessment | Patient unexpectedly died from a myocardial infarct. Cause of death determined by PCP. Unrelated to study intervention. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea from Medication | Gastrointestinal disorders | Non-systematic Assessment | 1 was unrelated to participation 1 was related (rifampin) |
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| Hallucinations | Nervous system disorders | Non-systematic Assessment | unrelated to study participation |
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| Muscle Aches | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | related to statin use, started prior to consent |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Meghan Brennan, MD, MS | UW School of Medicine and Public Health | (608) 263-1545 | mbbrennan@medicine.wisc.edu |
| Jun 30, 2025 |
| Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Nov 28, 2022 | May 13, 2025 | ICF_000.pdf |
| ID | Term |
|---|---|
| D017719 | Diabetic Foot |
| ID | Term |
|---|---|
| D003925 | Diabetic Angiopathies |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D016523 | Foot Ulcer |
| D007871 | Leg Ulcer |
| D012883 | Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
| D003929 | Diabetic Neuropathies |
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| Hyperlipidemia (yes) |
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| Coronary artery disease (yes) |
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| Stroke/TIA (yes) |
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| Peripheral neuropathy (yes) |
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| Charcot arthropathy (yes) |
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| ACE inhibitor (yes) |
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| Angiotensin II receptor blocker (yes) |
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| Statin (yes) |
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