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

NCT ID: NCT05203471

Last Updated: 2025-07-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 114 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-16
• Study Completion Date: 2025-06-25

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.

Conditions

Diabetic Foot; Diabetic Ulcer of Left Foot; Diabetic Ulcer of Right Foot; Amputation

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: ACTIVE_COMPARATOR

integrated care model

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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

• 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

• Insufficient overlap in work schedules between rural providers and scheduler based on clinic manager determination.

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 89 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role: collaborator

University of Wisconsin, Madison

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Meghan B Brennan, MD

Role: PRINCIPAL_INVESTIGATOR

University of Wisconsin, Madison

Locations

University of Wisconsin-Madison

Madison, Wisconsin, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

R01DK132569-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

Protocol Version 2/6/2025

Identifier Type: OTHER

Identifier Source: secondary_id

SMPH/MEDICINE/INFECT DIS

Identifier Type: OTHER

Identifier Source: secondary_id

2022-1338

Identifier Type: -

Identifier Source: org_study_id