Diabetic FootNCT05203471
Crossing the Divide: Piloting Integrated Care to Reduce Amputations Among Rural Patients With Diabetic Foot Ulcers
A study testing integrated care model in people with Diabetic Foot and Diabetic Ulcer of Left Foot, run by University of Wisconsin, Madison at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Diabetic Foot, Diabetic Ulcer of Left Foot, Diabetic Ulcer of Right Foot
- What is being tested?
- integrated care model
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 131 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Feb 2023to 25 Jun 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- Healthcare worker exclusion criteria:
- Insufficient overlap in work schedules between rural providers and scheduler based on clinic manager determination.
- Patient exclusion criteria:
- receiving palliative care such that referral to urban centers for aggressive limb salvage would be inappropriate, as assessed by patient rural provider
- insurance does not cover referral to the University of Wisconsin's specialty clinics
- Not suitable for study participation due to other reasons at the discretion of the investigators.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Wisconsin-Madison
Madison, Wisconsin, 53705
About this study
Official title: Crossing the Divide: Piloting an Integrated Care Model to Bridge Rural-urban Healthcare Systems and Reduce Major Amputations Among Rural Patients With Diabetic Foot Ulcers
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.
- Being tested
- integrated care model
- Keywords
- Multidisciplinary care, Integrated care, Rural disparities, Recruitment, Retention
- Medical subject headings
- Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
integrated care modelOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: integrated care model |
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: up to 3 months
Secondary outcomes (1)
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.
Measured: up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2022
- Study start16 Feb 2023
- Primary completion1 May 2025
- Study completion25 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Diabetic FootStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Sequential
- 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.
- Masking
- None (open label)
- Enrolment
- 131 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Meghan B Brennan, MD, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05203471
- Sponsor's protocol ID
- 2022-1338
- Other IDs
- R01DK132569-01, Protocol Version 2/6/2025, SMPH/MEDICINE/INFECT DIS
- Status last verified
- Apr 2026
- First submitted
- 10 Jan 2022
- Last updated
- 27 Apr 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Crossing the Divide: Piloting an Integrated Care Model to Bridge Rural-urban Healthcare Systems and Reduce Major Amputations Among Rural Patients With Diabetic Foot Ulcers
- ClinicalTrials.gov ID
- NCT05203471
- Acronym / sponsor ID
- 2022-1338
- Keywords
- Multidisciplinary care, Integrated care, Rural disparities, Recruitment, Retention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 131 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 16 Feb 2023 (actual)
- Primary completion
- 1 May 2025 (actual)
- Study completion
- 25 Jun 2025 (actual)
- First posted
- 24 Jan 2022 (actual)
- Results
- Posted 27 Apr 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| 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 | Other: integrated care modelPatients 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 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. |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Healthcare worker inclusion criteria:
- Patient inclusion criteria:
Key exclusion criteria (6 listed)
- Healthcare worker exclusion criteria:
- Patient exclusion criteria:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| integrated care modelThe 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. | Other | Integrated care |
Primary outcome
Proportion of Patients Receiving Guideline-concordant Vascular and Infectious Disease Care Processes
Time frame: 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)
1 secondary outcome
Proportion of Patients Undergoing Amputation
Time frame: up to 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. 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.
Related trials for Diabetic Foot
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Continuous Monitoring of Plantar Temperature Variations Using Connected Insoles and a Mobile Application for Diabetic Foot.
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Wound Heal, Diabetic Foot Ulcer
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DiaFootCare to Promote Self-Care of Diabetic Foot Ulcers in Oman
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Better Care Closer to Home: Enhancing Primary and Community Care
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Comparison of Negative Pressure Wound Therapy Versus Moist Wound Dressing in Diabetic Foot Ulcer Patients
Diabetic Foot Ulcer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Meghan B Brennan, MD principal investigator
University of Wisconsin, Madison
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing integrated care model in people with Diabetic Foot and Diabetic Ulcer of Left Foot, run by University of Wisconsin, Madison at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Apr 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Patients Receiving Guideline-concordant Vascular and Infectious Disease Care Processes (time frame: up to 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2026.