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Integrated Care Model for Diabetic Foot Ulcers

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Waitlist Available

Led By Meghan B Brennan, MD

Research Sponsored by University of Wisconsin, Madison

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patient inclusion criteria: Patient with either type 1 or type 2 diabetes at a participating rural clinic

Patient inclusion criteria: Develops diabetic foot ulcer during enrollment period

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years and 3 months

Awards & highlights

Study Summary

This trial is testing a model of care that has been successful in reducing major amputations in urban settings by approximately 40%.

Who is the study for?

This trial is for healthcare workers and patients in rural clinics. Workers must consent, be employed at a participating clinic, available throughout the study, and follow procedures. Patients need to consent, be 18+, have type 1 or type 2 diabetes, develop a foot ulcer during enrollment, and comply with the study. Exclusions include insurance issues and unsuitability for aggressive treatment.Check my eligibility

What is being tested?

The trial tests an integrated care model adapted for rural settings to reduce major amputations caused by diabetic foot ulcers. It aims to gather data on recruitment strategies and provide preliminary evidence of efficacy that could lead to a larger statewide trial.See study design

What are the potential side effects?

Since this is not a drug intervention but rather an integrated care approach being tested, there are no direct side effects like those associated with medication. However, changes in care may affect patient comfort or satisfaction.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have diabetes and am treated at a rural clinic.

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I developed a diabetic foot ulcer while enrolled in the study.

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I am 18 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years and 3 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 years and 3 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years and 3 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Proportion of patients receiving guideline-concordant vascular and infectious disease care processes

Secondary outcome measures

Proportion of patients undergoing amputation

Other outcome measures

Patient recruitment rate

Patient retention rate

Trial Design

2Treatment groups

Active Control

Group I: Historical controlsActive Control1 Intervention

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

Group II: Integrated careActive Control1 Intervention

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.

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of Wisconsin, MadisonLead Sponsor

1,182 Previous Clinical Trials

3,167,150 Total Patients Enrolled

1 Trials studying Diabetic Foot

10 Patients Enrolled for Diabetic Foot

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

2,356 Previous Clinical Trials

4,314,829 Total Patients Enrolled

14 Trials studying Diabetic Foot

7,207 Patients Enrolled for Diabetic Foot

Meghan B Brennan, MDPrincipal InvestigatorUniversity of Wisconsin, Madison

Media Library

Integrated Care Model (N/A) Clinical Trial Eligibility Overview. Trial Name: NCT05203471 — N/A

Diabetic Foot Research Study Groups: Historical controls, Integrated care

Diabetic Foot Clinical Trial 2023: Integrated Care Model Highlights & Side Effects. Trial Name: NCT05203471 — N/A

Integrated Care Model (N/A) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05203471 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Can individuals less than 75 years of age partake in this trial?

"The requirements for this medical experiment specify that participants must be above the age of majority and younger than 89."

Answered by AI

Could I be considered a participant in this research project?

"This research aims to gather 120 individuals with diabetic foot that meet two criteria: they must be between 18 and 89 years old, and have a current diabetic foot ulcer. To qualify for the trial, it is also essential that either the patient or their primary care provider works at one of three participating clinics as a provider or scheduler/referral coordinator."

Answered by AI

Are there any availabilities for volunteers in this research study?

"Records on clinicaltrials.gov demonstrate that this health trial is no longer searching for candidates, as it was first posted in December of 2022 and last updated in November of the same year. Nevertheless, there are still 453 other medical studies actively recruiting participants at present."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2023. "Crossing the Divide: Piloting Integrated Care to Reduce Amputations Among Rural Patients With Diabetic Foot Ulcers". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05203471.