Crossing the Divide: Piloting Integrated Care to Reduce Amputations Among Rural Patients With Diabetic Foot Ulcers

April 23, 2026 updated by: University of Wisconsin, Madison

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
131

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Wisconsin
      • Madison, Wisconsin, United States, 53705
        • University of Wisconsin-Madison

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 89 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: 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.
Active Comparator: 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.
Other: 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.
No Intervention: Healthcare Worker
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 the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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)
up to 3 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Proportion of Patients Undergoing Amputation
Time Frame: 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.
up to 3 months

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Patient Recruitment Rate
Time Frame: up to 3 months
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
Time Frame: up to 3 months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Wisconsin, Madison

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Meghan B Brennan, MD, University of Wisconsin, Madison

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 16, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 25, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 10, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 10, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 24, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 27, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 23, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2022-1338
  • R01DK132569-01 (U.S. NIH Grant/Contract)
  • SMPH/MEDICINE/INFECT DIS (Other Identifier: UW Madison)
  • Protocol Version 2/6/2025 (Other Identifier: UW Madison)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing Time Frame

Beginning 9 months after publication of primary outcomes and ending 5 years after that date.

IPD Sharing Access Criteria

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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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