Peer Support for Diabetic Foot Ulcers

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: Unknown

24 Participants Needed

Trial Summary

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 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. ^{1 2 3 4 5}

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. ^{5 6 7 8 9}

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. ^{2 7 10 11 12}

Research Team

Emily Rosario, PhD

Principal Investigator

Casa Colina Hospital and Centers for Healthcare

Eligibility Criteria

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 speak English or Spanish.

I am older than 18 years.

Exclusion Criteria

I am not willing to join the PAI program.

Incarceration or institutionalization

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

References

1. England 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. [2022]

2. India pubmed.ncbi.nlm.nih.gov

The Effect of Peer Support on Foot Care in Patients with Type 2 Diabetes. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Peer supporters for cardiac patients with diabetes: a randomized controlled trial. [2012]

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

Peer support for patients with type 2 diabetes: cluster randomised controlled trial. [2022]

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

Peer coaching to improve diabetes self-management: which patients benefit most? [2022]

6. India pubmed.ncbi.nlm.nih.gov

Establishing peer support groups for diabetic retinopathy in India: Lessons learned and way ahead. [2020]

7. England 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. [2018]

8. England 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. [2022]

9. England pubmed.ncbi.nlm.nih.gov

Real-world insights from launching remote peer-to-peer mentoring in a safety net healthcare delivery setting. [2022]

10. England pubmed.ncbi.nlm.nih.gov

Prevention of foot ulcers in persons with diabetes at risk of ulceration: A systematic review and meta-analysis. [2023]

11. France pubmed.ncbi.nlm.nih.gov

[Diabetic foot]. [2022]

12. England pubmed.ncbi.nlm.nih.gov

Development and validation of a pocket guide for the prevention of diabetic foot ulcers. [2022]