Crossing the Divide: Piloting Integrated Care to Reduce Amputations Among Rural Patients With Diabetic Foot Ulcers
Completed · Not applicable
Conditions studied: Diabetic Foot, Diabetic Ulcer of Left Foot, Diabetic Ulcer of Right Foot, Amputation
In brief
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.
Key facts
- Study ID
- NCT05203471
- Run by
- University of Wisconsin, Madison
- People needed
- 131
- Starts
- 2023-02-16
- Expected to finish
- 2025-06-25
- Last updated by the study team
- 2026-04-27
Who can join
Age: 18 and older, up to 89. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- University of Wisconsin-Madison — Madison, Wisconsin, United States
Full record on ClinicalTrials.gov
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