Crossing the Divide: Piloting Integrated Care to Reduce Amputations Among Rural Patients With Diabetic Foot Ulcers
Key facts
- Who runs it
- University of Wisconsin, Madison
- Where
- Madison, United StatesSee the site
- Trial code
- Status
- Completed
- People taking part
- 131 people enrolled
- Started
- 16 Feb 2023
- Ended
- 25 Jun 2025
- Type of study
- Interventional, 3 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- integrated care model
- Record updated
- 27 April 2026
Who can take part
- Age
- 18 years to 89 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 4 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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
- Healthcare worker exclusion criteria:; Insufficient overlap in work schedules between rural providers and scheduler based on clinic manager determination
Where in United States
- University of Wisconsin - MadisonMadison, United States
About the trial
What the trial wants to find out
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.
The 3 groups in the trial
- Historical controlsNo study treatment, for comparison
Patients with diabetic foot ulcers cared for by a primary care provider participating in the study prior to launching the integrated care intervention.
- Integrated careExisting treatment, for comparison
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.
Treatment: integrated care model
- Healthcare WorkerNo study treatment, for comparison
Healthcare worker employed in a clinic that agreed to take part in this study and provides care for patients with diabetic foot ulcers.
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- 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
- Record updated
- 27 April 2026