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

Not Applicable

Completed

• Conditions: Diabetic Foot; Diabetic Ulcer of Right Foot; Diabetic Ulcer of Left Foot; Amputation
• Interventions: Other: integrated care model

• Registration Number: NCT05203471
• Lead Sponsor: University of Wisconsin, Madison

Brief 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. 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-01-10
• Study First Submitted QC: 2022-01-10
• Study First Posted: 2022-01-24
• Study Start: 2023-02-16
• Status Verified: 2025-05
• Primary Completion: 2025-05-01
• Study Completion: 2025-05-01
• Last Update Submitted: 2025-05-13
• Last Update Posted: 2025-05-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 114

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Integrated care	integrated care model	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.

Primary Outcome Measures

Name	Time	Method
Proportion of patients receiving guideline-concordant vascular and infectious disease care processes	up to 2 years and 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)

Secondary Outcome Measures

Name	Time	Method
Proportion of patients undergoing amputation	up to 2 years and 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 or minor amputation of the ipsilateral lower extremity to the index ulcer

Trial Locations

Locations (1)

University of Wisconsin-Madison; 🇺🇸 Madison, Wisconsin, United States