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Completed

NCT Number: NCT05203471

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

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.

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Key information

Conditions

Diabetic Foot Amputation Cardiovascular Diseases Diabetes Complications Diabetes Mellitus Diabetic Angiopathies Diabetic Neuropathies Diabetic Ulcer of Left Foot Diabetic Ulcer of Right Foot Endocrine System Diseases Foot Ulcer Leg Ulcer Skin Diseases Skin Ulcer Skin and Connective Tissue Diseases Vascular Diseases

Age range

18 year–89 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Wisconsin-Madison

Madison, Wisconsin, 53705, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

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

    Time frame: up to 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 outcomes

  1. Proportion of Patients Undergoing Amputation

    Time frame: up to 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 (above the ankle) or minor amputation (below the ankle) of the ipsilateral lower extremity to the index ulcer.

Other outcomes

  1. Patient Recruitment Rate

    Time frame: up to 3 months

    Number of patients who enrolled in the study divided by the number of patients the study team attempted to contact for study recruitment

  2. Patient Retention Rate

    Time frame: up to 3 months

    Number of patients who completed the 3-month follow-up telephone call divided by the number of patients who enrolled in the study

Sponsors and collaborators

Lead sponsor

University of Wisconsin, Madison

Other

Collaborators

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

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Jan 24, 2022
Registry last updated
Apr 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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