Trial Outcomes & Findings for Crossing the Divide: Piloting Integrated Care to Reduce Amputations Among Rural Patients With Diabetic Foot Ulcers (NCT NCT05203471)
NCT ID: NCT05203471
Last Updated: 2026-04-27
Results Overview
(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)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
131 participants
Primary outcome timeframe
up to 3 months
Results posted on
2026-04-27
Participant Flow
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.
Participant milestones
| Measure |
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.
|
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.
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.
|
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.
|
|---|---|---|---|
|
Overall Study
STARTED
|
81
|
27
|
23
|
|
Overall Study
COMPLETED
|
81
|
26
|
23
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
0
|
Reasons for withdrawal
| Measure |
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.
|
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.
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.
|
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.
|
|---|---|---|---|
|
Overall Study
Death
|
0
|
1
|
0
|
Baseline Characteristics
Healthcare Workers were not the target population for data collection. Study relevant baseline data not collected from Healthcare Workers per protocol.
Baseline characteristics by cohort
| Measure |
Historical Controls
n=81 Participants
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
n=27 Participants
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.
|
Healthcare Workers
n=23 Participants
Healthcare worker employed in a clinic that agreed to take part in this study and provides care for patients with diabetic foot ulcers.
|
Total
n=131 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
64.5 years
n=81 Participants • Healthcare Workers were not the target population for data collection. Study relevant baseline data not collected from Healthcare Workers per protocol.
|
62.7 years
n=27 Participants • Healthcare Workers were not the target population for data collection. Study relevant baseline data not collected from Healthcare Workers per protocol.
|
—
|
64.05 years
n=108 Participants • Healthcare Workers were not the target population for data collection. Study relevant baseline data not collected from Healthcare Workers per protocol.
|
|
Sex: Female, Male
Female
|
23 Participants
n=81 Participants
|
2 Participants
n=27 Participants
|
20 Participants
n=23 Participants
|
45 Participants
n=131 Participants
|
|
Sex: Female, Male
Male
|
58 Participants
n=81 Participants
|
25 Participants
n=27 Participants
|
3 Participants
n=23 Participants
|
86 Participants
n=131 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=81 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=23 Participants
|
0 Participants
n=131 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
78 Participants
n=81 Participants
|
26 Participants
n=27 Participants
|
11 Participants
n=23 Participants
|
115 Participants
n=131 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=81 Participants
|
1 Participants
n=27 Participants
|
12 Participants
n=23 Participants
|
16 Participants
n=131 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=81 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=23 Participants
|
1 Participants
n=131 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=81 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=23 Participants
|
0 Participants
n=131 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=81 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=23 Participants
|
0 Participants
n=131 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=81 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=23 Participants
|
0 Participants
n=131 Participants
|
|
Race (NIH/OMB)
White
|
79 Participants
n=81 Participants
|
27 Participants
n=27 Participants
|
10 Participants
n=23 Participants
|
116 Participants
n=131 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=81 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=23 Participants
|
0 Participants
n=131 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=81 Participants
|
0 Participants
n=27 Participants
|
12 Participants
n=23 Participants
|
14 Participants
n=131 Participants
|
|
Region of Enrollment
United States
|
81 participants
n=81 Participants
|
27 participants
n=27 Participants
|
23 participants
n=23 Participants
|
131 participants
n=131 Participants
|
|
Area Deprivation Index (ADI)
|
3.8 units on a scale
n=81 Participants • Healthcare Workers were not the target population for data collection. Study relevant baseline data not collected from them per protocol.
|
4.2 units on a scale
n=27 Participants • Healthcare Workers were not the target population for data collection. Study relevant baseline data not collected from them per protocol.
|
—
|
3.9 units on a scale
n=108 Participants • Healthcare Workers were not the target population for data collection. Study relevant baseline data not collected from them per protocol.
|
|
Body Mass Index (BMI)
|
35.8 kilograms per meter squared
n=81 Participants • Healthcare Workers were not the target population for data collection. Study relevant baseline data not collected from them per protocol.
|
34.2 kilograms per meter squared
n=27 Participants • Healthcare Workers were not the target population for data collection. Study relevant baseline data not collected from them per protocol.
|
—
|
35.4 kilograms per meter squared
n=108 Participants • Healthcare Workers were not the target population for data collection. Study relevant baseline data not collected from them per protocol.
|
|
Tobacco Status
Never User
|
35 Participants
n=81 Participants • Healthcare Workers were not the target population for data collection. Study relevant baseline data not collected from them per protocol.
|
13 Participants
n=27 Participants • Healthcare Workers were not the target population for data collection. Study relevant baseline data not collected from them per protocol.
|
—
|
48 Participants
n=108 Participants • Healthcare Workers were not the target population for data collection. Study relevant baseline data not collected from them per protocol.
|
|
Tobacco Status
Current User
|
13 Participants
n=81 Participants • Healthcare Workers were not the target population for data collection. Study relevant baseline data not collected from them per protocol.
|
4 Participants
n=27 Participants • Healthcare Workers were not the target population for data collection. Study relevant baseline data not collected from them per protocol.
|
—
|
17 Participants
n=108 Participants • Healthcare Workers were not the target population for data collection. Study relevant baseline data not collected from them per protocol.
|
|
Tobacco Status
Former User
|
33 Participants
n=81 Participants • Healthcare Workers were not the target population for data collection. Study relevant baseline data not collected from them per protocol.
|
10 Participants
n=27 Participants • Healthcare Workers were not the target population for data collection. Study relevant baseline data not collected from them per protocol.
|
—
|
43 Participants
n=108 Participants • Healthcare Workers were not the target population for data collection. Study relevant baseline data not collected from them per protocol.
|
|
Preexisting Conditions
Hypertension (yes)
|
70 Participants
n=81 Participants • Healthcare Workers were not the target population for data collection. Study relevant baseline data not collected from them per protocol.
|
21 Participants
n=27 Participants • Healthcare Workers were not the target population for data collection. Study relevant baseline data not collected from them per protocol.
|
—
|
91 Participants
n=108 Participants • Healthcare Workers were not the target population for data collection. Study relevant baseline data not collected from them per protocol.
|
|
Preexisting Conditions
Hyperlipidemia (yes)
|
61 Participants
n=81 Participants • Healthcare Workers were not the target population for data collection. Study relevant baseline data not collected from them per protocol.
|
24 Participants
n=27 Participants • Healthcare Workers were not the target population for data collection. Study relevant baseline data not collected from them per protocol.
|
—
|
85 Participants
n=108 Participants • Healthcare Workers were not the target population for data collection. Study relevant baseline data not collected from them per protocol.
|
|
Preexisting Conditions
Coronary artery disease (yes)
|
26 Participants
n=81 Participants • Healthcare Workers were not the target population for data collection. Study relevant baseline data not collected from them per protocol.
|
12 Participants
n=27 Participants • Healthcare Workers were not the target population for data collection. Study relevant baseline data not collected from them per protocol.
|
—
|
38 Participants
n=108 Participants • Healthcare Workers were not the target population for data collection. Study relevant baseline data not collected from them per protocol.
|
|
Preexisting Conditions
Stroke/TIA (yes)
|
6 Participants
n=81 Participants • Healthcare Workers were not the target population for data collection. Study relevant baseline data not collected from them per protocol.
|
5 Participants
n=27 Participants • Healthcare Workers were not the target population for data collection. Study relevant baseline data not collected from them per protocol.
|
—
|
11 Participants
n=108 Participants • Healthcare Workers were not the target population for data collection. Study relevant baseline data not collected from them per protocol.
|
|
Preexisting Conditions
Peripheral neuropathy (yes)
|
62 Participants
n=81 Participants • Healthcare Workers were not the target population for data collection. Study relevant baseline data not collected from them per protocol.
|
24 Participants
n=27 Participants • Healthcare Workers were not the target population for data collection. Study relevant baseline data not collected from them per protocol.
|
—
|
86 Participants
n=108 Participants • Healthcare Workers were not the target population for data collection. Study relevant baseline data not collected from them per protocol.
|
|
Preexisting Conditions
Charcot arthropathy (yes)
|
11 Participants
n=81 Participants • Healthcare Workers were not the target population for data collection. Study relevant baseline data not collected from them per protocol.
|
6 Participants
n=27 Participants • Healthcare Workers were not the target population for data collection. Study relevant baseline data not collected from them per protocol.
|
—
|
17 Participants
n=108 Participants • Healthcare Workers were not the target population for data collection. Study relevant baseline data not collected from them per protocol.
|
|
Baseline Medications
Anticoagulant (yes)
|
61 Participants
n=81 Participants • Healthcare Workers were not the target population for data collection. Study relevant baseline data not collected from them per protocol.
|
22 Participants
n=27 Participants • Healthcare Workers were not the target population for data collection. Study relevant baseline data not collected from them per protocol.
|
—
|
83 Participants
n=108 Participants • Healthcare Workers were not the target population for data collection. Study relevant baseline data not collected from them per protocol.
|
|
Baseline Medications
ACE inhibitor (yes)
|
46 Participants
n=81 Participants • Healthcare Workers were not the target population for data collection. Study relevant baseline data not collected from them per protocol.
|
10 Participants
n=27 Participants • Healthcare Workers were not the target population for data collection. Study relevant baseline data not collected from them per protocol.
|
—
|
56 Participants
n=108 Participants • Healthcare Workers were not the target population for data collection. Study relevant baseline data not collected from them per protocol.
|
|
Baseline Medications
Angiotensin II receptor blocker (yes)
|
12 Participants
n=81 Participants • Healthcare Workers were not the target population for data collection. Study relevant baseline data not collected from them per protocol.
|
3 Participants
n=27 Participants • Healthcare Workers were not the target population for data collection. Study relevant baseline data not collected from them per protocol.
|
—
|
15 Participants
n=108 Participants • Healthcare Workers were not the target population for data collection. Study relevant baseline data not collected from them per protocol.
|
|
Baseline Medications
Statin (yes)
|
57 Participants
n=81 Participants • Healthcare Workers were not the target population for data collection. Study relevant baseline data not collected from them per protocol.
|
23 Participants
n=27 Participants • Healthcare Workers were not the target population for data collection. Study relevant baseline data not collected from them per protocol.
|
—
|
80 Participants
n=108 Participants • Healthcare Workers were not the target population for data collection. Study relevant baseline data not collected from them per protocol.
|
PRIMARY outcome
Timeframe: 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)
Outcome measures
| Measure |
Integrated Care
n=27 Participants
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
n=81 Participants
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.
|
|---|---|---|
|
Proportion of Patients Receiving Guideline-concordant Vascular and Infectious Disease Care Processes
|
6 Participants
|
14 Participants
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Integrated Care
n=27 Participants
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
n=81 Participants
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.
|
|---|---|---|
|
Proportion of Patients Undergoing Amputation
Minor Amputations
|
3 Participants
|
10 Participants
|
|
Proportion of Patients Undergoing Amputation
Major Amputations
|
0 Participants
|
4 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: up to 3 monthsPopulation: Number of participants analyzed here represents the number of people approached to participate
Number of patients who enrolled in the study divided by the number of patients the study team attempted to contact for study recruitment
Outcome measures
| Measure |
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.
|
Integrated Care
n=29 Participants
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.
|
|---|---|---|
|
Patient Recruitment Rate
|
—
|
27 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: up to 3 monthsNumber of patients who completed the 3-month follow-up telephone call divided by the number of patients who enrolled in the study
Outcome measures
| Measure |
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.
|
Integrated Care
n=27 Participants
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.
|
|---|---|---|
|
Patient Retention Rate
|
—
|
27 Participants
|
Adverse Events
Historical Controls
Serious events: 0 serious events
Other events: 0 other events
Deaths: 3 deaths
Integrated Care
Serious events: 2 serious events
Other events: 4 other events
Deaths: 1 deaths
Healthcare Workers
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
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.
|
Integrated Care
n=27 participants at risk
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.
|
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.
|
|---|---|---|---|
|
Injury, poisoning and procedural complications
deep space abscess
|
—
0/0 • 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.
|
3.7%
1/27 • 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.
|
—
0/0 • 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.
|
|
Cardiac disorders
Myocardial Infarction
|
—
0/0 • 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.
|
3.7%
1/27 • 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.
|
—
0/0 • 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.
|
Other adverse events
| Measure |
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.
|
Integrated Care
n=27 participants at risk
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.
|
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.
|
|---|---|---|---|
|
Gastrointestinal disorders
Nausea from Medication
|
—
0/0 • 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.
|
7.4%
2/27 • Number of events 2 • 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.
|
—
0/0 • 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.
|
|
Nervous system disorders
Hallucinations
|
—
0/0 • 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.
|
3.7%
1/27 • Number of events 1 • 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.
|
—
0/0 • 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.
|
|
Musculoskeletal and connective tissue disorders
Muscle Aches
|
—
0/0 • 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.
|
3.7%
1/27 • Number of events 1 • 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.
|
—
0/0 • 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.
|
Additional Information
Dr. Meghan Brennan, MD, MS
UW School of Medicine and Public Health
Phone: (608) 263-1545
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place