Integrated Care Model for Diabetic Foot Ulcers

Overseen By Jamie LaMantia

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Wisconsin, Madison

Disqualifiers: Palliative care, Insurance issues, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 3 months

114 Participants Needed

Trial Summary

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.

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. ^{1 2 3 4 5}

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. ^{2 3 6 7 8}

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. ^{8 9 10 11 12}

Research Team

Meghan B Brennan, MD

Principal Investigator

University of Wisconsin, Madison

Eligibility Criteria

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.

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

Timeline

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

Treatment Details

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.

Participant Groups

Group I: Historical controls Active Control 1 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 care Active Control 1 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.

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+

Findings from Research

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prognosis of the infected diabetic foot ulcer: a 12-month prospective observational study. Ndosi, M., Wright-Hughes, A., Brown, S., et al.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Decreasing amputation rates in patients with diabetes mellitus. An outcome study. [2022]

2. Switzerland pubmed.ncbi.nlm.nih.gov

The effect of collaborative care model training on diabetic foot ulcer patients' quality of life: a semi-experimental study. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

The process of implementing a rural VA wound care program for diabetic foot ulcer patients. [2007]

4. England pubmed.ncbi.nlm.nih.gov

Prognosis of the infected diabetic foot ulcer: a 12-month prospective observational study. [2022]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Evaluation of a multidisciplinary consultation of diabetic foot. [2010]

6. United States pubmed.ncbi.nlm.nih.gov

Preliminary development of a diabetic foot ulcer database from a wound electronic medical record: a tool to decrease limb amputations. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Amputations and foot-related hospitalisations disproportionately affect dialysis patients. [2022]

8. Switzerland pubmed.ncbi.nlm.nih.gov

[Preventive measures of diabetic foot complications]. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Preventing diabetic foot ulcers. [2005]

10. United States pubmed.ncbi.nlm.nih.gov

Wagner's Classification as a Tool for Treating Diabetic Foot Ulcers: Our Observations at a Suburban Teaching Hospital. [2022]

11. England pubmed.ncbi.nlm.nih.gov

Evaluation of the North West London Diabetes Foot Care Transformation Project: A Mixed-Methods Evaluation. [2023]

12. United States pubmed.ncbi.nlm.nih.gov

Toe and flow: essential components and structure of the amputation prevention team. [2022]