Peer Support for Diabetic Foot Ulcers

Not currently recruiting at 2 trial locations

Overseen By Tze-Woei Tan, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Casa Colina Hospital and Centers for Healthcare

Disqualifiers: Incarceration, Institutionalization, Unwillingness, others

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

Compensation: Varies

Number of Visits: 3

Duration: 6 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to develop a peer support program to help individuals with diabetic foot ulcers (DFUs) manage their condition more effectively. By comparing a peer support group to usual care, researchers aim to improve health outcomes and reduce disparities among economically disadvantaged patients. Ideal participants are those who have developed a new DFU within the last six months and can communicate in English or Spanish. As an unphased trial, this study offers participants the chance to contribute to innovative research that could lead to improved care strategies for DFUs.

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 prior data suggests that this peer support program is safe for patients with diabetic foot ulcers?

Research shows that peer support for foot care in people with diabetes is generally safe. Studies have found that peer counseling can improve foot care habits in those with diabetes. While the main goal is to enhance care behaviors, participants have managed the process well. No major reports of negative effects from the peer support itself have emerged. Participants usually find the support and education from peers valuable. This suggests the approach is safe and likely to provide a positive experience for those involved. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike standard treatments for diabetic foot ulcers that focus on medical and surgical interventions, peer support groups offer a unique approach by providing emotional and social support. This method could enhance patients' quality of life by addressing psychological aspects such as depression and social satisfaction through shared experiences. Researchers are excited because this approach may lead to improved overall well-being and adherence to care plans, potentially reducing ulcer complications and promoting healing.

What evidence suggests that peer support is effective for diabetic foot ulcers?

Research has shown that peer support, one of the approaches studied in this trial, can help people with diabetes improve foot care. Participants in the Peer Support Group will receive support from others with similar experiences, which studies have found often leads to better foot care practices. This approach not only enhances self-care but also aids in more effective condition management. Peer support offers an affordable way to enhance the overall treatment experience through encouragement and shared learning. It is particularly useful in motivating patients to address their own health needs. ^{1 6 7 8 9}

Who Is on the Research Team?

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?

Group I: Peer Support Group Experimental Treatment 1 Intervention

Patients will be asked to complete a health-related quality of life (HRQOL) survey at enrollment, 3 months, and end of the study. Participants will complete the VascuQoL-6 and PROMIS in several domains of HRQOL (including global physical function, global mental function, fatigue, depression, sleep disturbance, pain behavior, and social satisfaction). Each participant will complete the PROMIS CAT tool on an iPad App and the data will be stored in the secure REDCap

Group II: Usual Care Group Active Control 1 Intervention

Subjects in this group will not participate in the peer group.

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

Peer support programs can significantly enhance social and emotional support for adults with diabetes, helping them manage their condition more effectively between healthcare visits.

These programs not only assist with daily diabetes management but also promote connections to clinical care, indicating a promising avenue for improving patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Different models to mobilize peer support to improve diabetes self-management and clinical outcomes: evidence, logistics, evaluation considerations and needs for future research. Heisler, M.[2022]

Individuals at risk of diabetic foot ulcers face unique challenges that can hinder their ability to increase physical activity, including concerns about pain, depression, and self-efficacy.

Despite these challenges, physical activity is not contraindicated for at-risk patients, and the review provides recommendations for safely implementing exercise interventions to help reduce the risk of foot ulcers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physiological and psychological challenges of increasing physical activity and exercise in patients at risk of diabetic foot ulcers: a critical review. Crews, RT., Schneider, KL., Yalla, SV., et al.[2018]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effect of Peer Support on Foot Care in Patients with Type 2 Diabetes. Ghasemi, Z., Yousefi, H., Torabikhah, M.[2022]

A multidisciplinary approach to managing diabetic foot ulcers, involving both in-patient and out-patient care, significantly improves patient outcomes and reduces the risk of amputations.

Identifying high-risk patients early, such as those with sensory loss or previous ulcers, is crucial, and France needs to enhance its foot-care programs through education, regular examinations, and the formation of specialized care teams.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Diabetic foot]. Chauchard, MC., Cousty-Pech, F., Martini, J., et al.[2022]

In a real-world evaluation of a remote diabetes intervention involving 974 patients, 71% enrolled and 90% of those participated in coaching, demonstrating high engagement in the program.

Participants who completed the program showed a significant reduction in hemoglobin A1c levels by 1.71%, indicating improved diabetes management through remote peer mentoring.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Real-world insights from launching remote peer-to-peer mentoring in a safety net healthcare delivery setting. Lyles, CR., Sarkar, U., Patel, U., et al.[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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Peer supporters for cardiac patients with diabetes: a randomized controlled trial. Wu, CJ., Chang, AM., Courtney, M., et al.[2012]

A two-year peer support intervention for patients with type 2 diabetes, involving 395 participants across 20 practices, did not show significant improvements in key health measures like HbA1c, blood pressure, or cholesterol levels compared to a control group.

While there was a slight trend towards better control of blood pressure in the intervention group, the overall results indicate that peer support may not be effective for all patients with type 2 diabetes, suggesting limited benefits for widespread implementation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Peer support for patients with type 2 diabetes: cluster randomised controlled trial. Smith, SM., Paul, G., Kelly, A., et al.[2022]

A systematic review of 40 controlled studies, including 33 randomized controlled trials, found that temperature monitoring and pressure-optimised therapeutic footwear significantly reduce the risk of plantar foot ulcer recurrence in high-risk individuals with diabetes, with moderate certainty evidence.

Other interventions, such as structured education and integrated care, showed potential benefits in reducing foot ulceration risk, but the evidence was of lower certainty, highlighting the need for more high-quality research in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prevention of foot ulcers in persons with diabetes at risk of ulceration: A systematic review and meta-analysis. van Netten, JJ., Raspovic, A., Lavery, LA., et al.[2023]

Peer support groups (PSGs) established in community health centers (CHCs) were more effective and sustainable than those in an eye hospital, with 83% of CHC members reporting satisfaction and positive lifestyle changes, such as regular medication adherence and dietary modifications.

The study involved 195 participants attending 53 sessions across 11 PSGs, highlighting the importance of location and support in diabetes management, as attendance declined in the eye hospital group due to barriers like distance and lack of family support.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Establishing peer support groups for diabetic retinopathy in India: Lessons learned and way ahead. Gudlavalleti, AG., Gilbert, C., Shukla, R., et al.[2020]

A new pocket guide was developed to help healthcare professionals prevent diabetic foot ulcers, which can lead to serious complications like amputation, based on evidence from the 2015 guidelines by the International Working Group on the Diabetic Foot.

The guide emphasizes five key strategies: regular foot examinations, risk assessments for ulceration, diabetes education, proper footwear, and treatment of early lesions, and it was validated with high content validity scores, ensuring its effectiveness in promoting quality care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development and validation of a pocket guide for the prevention of diabetic foot ulcers. Lucoveis, MDLS., Rolim, LCSP., Pedrosa, HC., et al.[2022]

Peer health coaching significantly lowers hemoglobin A1c (A1c) levels in patients with diabetes who have low self-management and medication adherence, indicating its effectiveness in high-risk groups.

In contrast, patients with high self-management and adherence showed similar improvements in A1c regardless of whether they received coaching or usual care, suggesting that coaching is particularly beneficial for those struggling with diabetes management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Peer coaching to improve diabetes self-management: which patients benefit most? Moskowitz, D., Thom, DH., Hessler, D., et al.[2022]

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PDF | Peer group support plays a crucial role in enhancing diabetic foot care. However, diabetic patients often exhibit suboptimal foot care behavior.