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

NCT05203471 | Completed Results DMC

• 4 other identifiers: 2022-1338R01DK132569-01Protocol Version 2/6/2025SMPH/MEDICINE/INFECT DIS
• Study Type: interventional
• Target: 131
• Locations: 1 country
• Sites: 1

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

Keywords

Multidisciplinary care; Integrated care; Rural disparities; Recruitment; Retention

Outcome Measures

Primary Outcomes (1)

• Proportion of Patients Receiving Guideline-concordant Vascular and Infectious Disease Care Processes

  (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 Outcomes (1)

• Proportion of Patients Undergoing Amputation

  up to 3 months

Other Outcomes (2)

• Patient Recruitment Rate

  up to 3 months

• Patient Retention Rate

  up to 3 months

Study Arms (3)

Historical controls

NO INTERVENTION

Patients with diabetic foot ulcers cared for by a primary care provider participating in the study prior to launching the integrated care intervention.

Integrated care

ACTIVE COMPARATOR

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

Healthcare Worker

NO INTERVENTION

Healthcare worker employed in a clinic that agreed to take part in this study and provides care for patients with diabetic foot ulcers.

Interventions

integrated care model 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.

Integrated care

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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:

• 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.

Sponsors & Collaborators

• University of Wisconsin, Madison: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

University of Wisconsin-Madison

Madison, Wisconsin, 53705, United States

Location

MeSH Terms

Conditions

Diabetic Foot

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies

Results Point of Contact

• Title: Dr. Meghan Brennan, MD, MS
• Organization: UW School of Medicine and Public Health

mbbrennan@medicine.wisc.edu

(608) 263-1545

Study Officials

• Meghan B Brennan, MD

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is an adaptive study design where recruitment and retention protocols are modified to improve involvement of rural study participants over three waves. Actively enrolled participants receive/ provide care for diabetic foot ulcers using a care algorithm and referral checklist. Results are compared to historical controls.

Study Record Dates

• First Submitted: January 10, 2022
• First Posted: January 24, 2022
• Study Start: February 16, 2023
• Primary Completion: May 1, 2025
• Study Completion: June 25, 2025
• Last Updated: April 27, 2026
• Results First Posted: April 27, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Beginning 9 months after publication of primary outcomes and ending 5 years after that date.
• 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.

Locations

US (1)