114 Participants Needed

Integrated Care Model for Diabetic Foot Ulcers

JL
Overseen ByJamie LaMantia
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of Wisconsin, Madison
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

Is the Integrated Care Model for Diabetic Foot Ulcers safe for humans?

The research does not provide specific safety data for the Integrated Care Model for Diabetic Foot Ulcers, but it mentions the use of standardized good wound care practices based on strong scientific evidence, which suggests a focus on safe treatment methods.12345

How does the Integrated Care Model treatment for diabetic foot ulcers differ from other treatments?

The Integrated Care Model for diabetic foot ulcers is unique because it emphasizes a collaborative, interdisciplinary approach involving various specialists, such as podiatrists and vascular surgeons, to address the complex needs of patients. This model focuses on co-production and sustainable change, aiming to improve care quality and reduce complications through a comprehensive, team-based strategy.46789

What data supports the effectiveness of the Integrated Care Model treatment for diabetic foot ulcers?

Research shows that using a team approach to care for diabetic foot problems significantly reduces the need for major amputations and improves outcomes. This suggests that a coordinated care model can be effective in managing diabetic foot ulcers.25101112

Who Is on the Research Team?

MB

Meghan B Brennan, MD

Principal Investigator

University of Wisconsin, Madison

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I have diabetes and am treated at a rural clinic.
Healthcare worker inclusion criteria: Employed at a participating clinic
I developed a diabetic foot ulcer while enrolled in the study.
See 6 more

Exclusion Criteria

Patient exclusion criteria: Insurance does not cover referral to the University of Wisconsin's specialty clinics
Healthcare worker exclusion criteria: Insufficient overlap in work schedules between rural providers and scheduler based on clinic manager determination
Patient exclusion criteria: Not suitable for study participation due to other reasons at the discretion of the investigators
See 1 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive integrated care for diabetic foot ulcers, focusing on reducing major amputations

3 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

up to 2 years and 3 months

What Are the Treatments Tested in This Trial?

Interventions

  • Integrated Care Model
Trial Overview 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.
How Is the Trial Designed?
2Treatment groups
Active Control
Group I: Historical controlsActive Control1 Intervention
Group II: Integrated careActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Wisconsin, Madison

Lead Sponsor

Trials
1,249
Recruited
3,255,000+

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

Collaborator

Trials
2,513
Recruited
4,366,000+

Published Research Related to This Trial

In a study of 299 participants with clinically infected diabetic foot ulcers, only 45.5% achieved healing within 12 months, highlighting the generally poor clinical outcomes for these patients.
Factors negatively impacting healing included longer ulcer duration (≥2 months) and higher PEDIS perfusion grades (≥2), while having a single ulcer was associated with better healing outcomes.
Prognosis of the infected diabetic foot ulcer: a 12-month prospective observational study.Ndosi, M., Wright-Hughes, A., Brown, S., et al.[2022]

Citations

Decreasing amputation rates in patients with diabetes mellitus. An outcome study. [2022]
The effect of collaborative care model training on diabetic foot ulcer patients' quality of life: a semi-experimental study. [2022]
The process of implementing a rural VA wound care program for diabetic foot ulcer patients. [2007]
Prognosis of the infected diabetic foot ulcer: a 12-month prospective observational study. [2022]
Evaluation of a multidisciplinary consultation of diabetic foot. [2010]
Preliminary development of a diabetic foot ulcer database from a wound electronic medical record: a tool to decrease limb amputations. [2022]
Amputations and foot-related hospitalisations disproportionately affect dialysis patients. [2022]
[Preventive measures of diabetic foot complications]. [2022]
Preventing diabetic foot ulcers. [2005]
10.United Statespubmed.ncbi.nlm.nih.gov
Wagner's Classification as a Tool for Treating Diabetic Foot Ulcers: Our Observations at a Suburban Teaching Hospital. [2022]
Evaluation of the North West London Diabetes Foot Care Transformation Project: A Mixed-Methods Evaluation. [2023]
12.United Statespubmed.ncbi.nlm.nih.gov
Toe and flow: essential components and structure of the amputation prevention team. [2022]
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