24 Participants Needed

Peer Support for Diabetic Foot Ulcers

Recruiting at 2 trial locations
NF
TT
Overseen ByTze-Woei Tan, MD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Casa Colina Hospital and Centers for Healthcare
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?

The objective of the study is to develop a peer support program that helps improve ulcer care in patients with a diabetic foot ulcer (DFU).Diabetes, peripheral arterial disease (PAD), foot ulceration, and subsequent amputation are unevenly patterned in terms of racial/ethnicity, socioeconomic status, health insurance, and geographic area. The project will identify opportunities to reduce health disparities among economically marginalized patients regarding DFU outcomes.

Do I have to stop taking my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications.

What safety data exists for peer support in treating diabetic foot ulcers?

The provided research does not directly address safety data for peer support in treating diabetic foot ulcers. However, it discusses the effectiveness and implementation of peer support in diabetes management, including self-management and lifestyle changes. The studies highlight the potential benefits of peer support in diabetes care, but specific safety data for diabetic foot ulcers is not mentioned.12345

Is peer support a promising treatment for diabetic foot ulcers?

Yes, peer support is a promising treatment for diabetic foot ulcers because it helps patients with diabetes take better care of their feet, which can prevent ulcers. It provides emotional and social support, encouraging patients to follow foot care routines and stay motivated.26789

What data supports the idea that Peer Support for Diabetic Foot Ulcers is an effective treatment?

The available research shows that peer support can be effective for people with diabetes, which includes those with diabetic foot ulcers. Studies have found that peer support helps improve self-management and foot care in patients with type 2 diabetes. This means that people who receive peer support are better at taking care of their feet, which can help prevent or manage foot ulcers. Compared to other treatments, peer support is beneficial because it involves people who have similar experiences, making it easier for patients to relate and learn from each other.46101112

Who Is on the Research Team?

ER

Emily Rosario, PhD

Principal Investigator

Casa Colina Hospital and Centers for Healthcare

Are You a Good Fit for This Trial?

This trial is for adults over 18 with a new ischemic diabetic foot ulcer less than 6 months old. Participants must be able to give consent and speak English or Spanish. It's not open to those who are incarcerated, institutionalized, or unwilling to join the peer support program.

Inclusion Criteria

Able to provide consent
I am older than 18 years.
My foot ulcer, caused by poor blood flow, is less than 6 months old.

Exclusion Criteria

I am not willing to join the PAI program.
Incarceration or institutionalization

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive peer support intervention and complete HRQOL surveys

6 months
3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Peer counseling group
Trial Overview The study is testing a peer counseling group designed to help patients manage their diabetic foot ulcers better. The goal is to see if this support can improve care and reduce health disparities among economically marginalized individuals.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: Peer Support GroupExperimental Treatment1 Intervention
Group II: Usual Care GroupActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Casa Colina Hospital and Centers for Healthcare

Lead Sponsor

Trials
11
Recruited
350+

University of Southern California

Collaborator

Trials
956
Recruited
1,609,000+

Vascular Cures

Collaborator

Trials
3
Recruited
120+

Department of Health and Human Services

Collaborator

Trials
240
Recruited
944,000+

Rancho Los Amigos National Rehabilitation Center

Collaborator

Trials
10
Recruited
2,000+

Published Research Related to This Trial

This study will evaluate the effectiveness of peer coaching in improving diabetes outcomes among 400 low-income patients with poorly controlled diabetes over a 6-month period, focusing on changes in HbA1c levels as the primary outcome.
Peer coaches, who are trained patients with diabetes, may enhance self-management skills and clinical outcomes, potentially providing a cost-effective solution to improve diabetes care in resource-limited settings.
The effectiveness of peer health coaching in improving glycemic control among low-income patients with diabetes: protocol for a randomized controlled trial.Ghorob, A., Vivas, MM., De Vore, D., et al.[2022]
Peer support significantly improved foot care behaviors and self-efficacy in 50 patients with type 2 diabetes, as shown by notable differences in scores before and after the intervention.
The study highlights the importance of using successful peers for education and support in diabetes care, suggesting that health agencies should incorporate these findings into their guidelines for better patient outcomes.
The Effect of Peer Support on Foot Care in Patients with Type 2 Diabetes.Ghasemi, Z., Yousefi, H., Torabikhah, M.[2022]
Incorporating patient peer supporters in a Cardiac-Diabetes Self-Management Program led to significantly greater improvements in knowledge about managing diabetes and cardiac conditions among participants compared to a control group of 30 patients.
While both groups showed improvements in self-care behavior and self-efficacy, the lack of significant differences in these areas suggests that further research with larger sample sizes is needed to fully understand the impact of peer support on these outcomes.
Peer supporters for cardiac patients with diabetes: a randomized controlled trial.Wu, CJ., Chang, AM., Courtney, M., et al.[2012]

Citations

The effectiveness of peer health coaching in improving glycemic control among low-income patients with diabetes: protocol for a randomized controlled trial. [2022]
The Effect of Peer Support on Foot Care in Patients with Type 2 Diabetes. [2022]
Peer supporters for cardiac patients with diabetes: a randomized controlled trial. [2012]
Peer support for patients with type 2 diabetes: cluster randomised controlled trial. [2022]
Peer coaching to improve diabetes self-management: which patients benefit most? [2022]
Establishing peer support groups for diabetic retinopathy in India: Lessons learned and way ahead. [2020]
Physiological and psychological challenges of increasing physical activity and exercise in patients at risk of diabetic foot ulcers: a critical review. [2018]
Different models to mobilize peer support to improve diabetes self-management and clinical outcomes: evidence, logistics, evaluation considerations and needs for future research. [2022]
Real-world insights from launching remote peer-to-peer mentoring in a safety net healthcare delivery setting. [2022]
Prevention of foot ulcers in persons with diabetes at risk of ulceration: A systematic review and meta-analysis. [2023]
[Diabetic foot]. [2022]
Development and validation of a pocket guide for the prevention of diabetic foot ulcers. [2022]
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