Integrated Care Model for Diabetic Foot Ulcers
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to reduce major amputations (removal of a limb) in people with diabetic foot ulcers, focusing on those in rural areas. It tests a new integrated care model, a coordinated healthcare approach, which has already reduced amputations in cities by about 40%. Participants include patients with type 1 or type 2 diabetes who develop foot ulcers while receiving care at specific rural clinics. The trial compares patients receiving the new care approach to those who received standard care before the trial. As an unphased trial, it offers patients the chance to contribute to innovative care solutions that could significantly improve outcomes for those with diabetic foot ulcers.
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 prior data suggests that this integrated care model is safe for patients with diabetic foot ulcers?
Research has shown that the integrated care model for treating diabetic foot ulcers is generally well-received and safe for patients. Past studies have demonstrated improvements in ulcer management with this approach. For instance, one study involving 2,798 patients showed promising results in wound care.
No specific safety issues have been reported, and this model has effectively reduced major amputations by about 40% in cities. This suggests safety, as better management typically leads to fewer complications.
It is important to note that the current trial is not in a specific phase, so there may be limited data on long-term safety. However, the model has been adapted from successful city programs, providing some confidence in its safety for patients in rural areas.12345Why are researchers excited about this trial?
Researchers are excited about the Integrated Care Model for diabetic foot ulcers because it offers a more comprehensive approach compared to traditional treatments, which often focus on isolated aspects of care like wound cleaning, dressing, and antibiotics. This model integrates various aspects of patient care, including coordination between multiple healthcare providers and personalized management strategies, which can lead to better overall outcomes. By fostering collaboration among healthcare providers, the integrated model aims to address the underlying causes of ulcers more effectively and reduce healing times, potentially leading to fewer amputations and improved quality of life for patients.
What evidence suggests that this integrated care model is effective for diabetic foot ulcers?
Research has shown that integrated care models, like the one tested in this trial, have reduced major amputations in cities by about 40%. One study examined 2,798 patients with diabetic foot ulcers (DFUs) and found that personalized, ongoing care improved management and accelerated wound healing. Personalized care models clearly benefit DFU healing, simplifying the management of these challenging wounds. Another study found that with traditional care, only 45.5% of DFU patients healed within a year, underscoring the need for improved methods like integrated care. These findings suggest that integrated care models can effectively treat diabetic foot ulcers, especially in rural areas where the risk of amputation is higher. Participants in this trial will receive care through the integrated care model, while historical controls will reflect outcomes from standard care before the intervention.26789
Who Is on the Research Team?
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive integrated care for diabetic foot ulcers, focusing on reducing major amputations
Follow-up
Participants are monitored for safety and effectiveness after treatment
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?
2
Treatment groups
Active Control
Patients with diabetic foot ulcers cared for by a primary care provider participating in the study prior to launching the integrated care 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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Wisconsin, Madison
Lead Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator
Published Research Related to This Trial
Citations
Outcome evaluation and cost-effectiveness analysis for an ...
We conducted an observational study to analyze 2798 patients with diabetic foot ulcers (DFUs) enrolled in the program between June 2020 and June ...
Effectiveness of personalized continuous care in wound ...
Overall, personalized continuous care demonstrates significant advantages in the management of diabetic foot ulcer (DFU) patients, as it promotes wound healing, ...
NCT03827902 | Diabetic Foot Ulcer and Wound Infection
The effectiveness of the technologically facilitated integrated model of care will be evaluated compared to the usual care using metrics for diabetic foot ...
Integrated Care Model for Diabetic Foot Ulcers
In a study of 299 participants with clinically infected diabetic foot ulcers, only 45.5% achieved healing within 12 months, highlighting the generally poor ...
Advancements and best practices in diabetic foot Care
This review aims to consolidate recent advancements and best practices in managing diabetic foot conditions, encompassing foot ulcers, neuropathy, vascular ...
Exploring diabetic foot screening programs with integrated ...
This review aims to analyze foot screening programs or initiatives for individuals at risk of DFUs and LEAs, define their key components and ...
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frontiersin.org
frontiersin.org/journals/clinical-diabetes-and-healthcare/articles/10.3389/fcdhc.2024.1440209/fullEmerging technologies for the management of diabetic foot ...
The presence of diabetic foot ulcers significantly increases mortality rates among patients with diabetes, surpassing that of diabetes alone (4) ...
Impact on management performance outcomes of ...
Implementing ICBs can help to improve wound management outcomes and reduce labor costs compared with non-standardized care without an ICB.
Outcome evaluation and cost-effectiveness analysis for an ...
We conducted an observational study to analyze 2798 patients with diabetic foot ulcers (DFUs) enrolled in the program between June 2020 and June ...
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