Peer Support for Patients With Diabetic Foot Ulcers

Last updated: December 4, 2023
Sponsor: Casa Colina Hospital and Centers for Healthcare
Overall Status: Active - Recruiting

Phase

N/A

Condition

Neurologic Disorders

Diabetes Mellitus Types I And Ii

Ulcers

Treatment

Peer counseling group

Clinical Study ID

NCT06004219
IRB:00002372
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age >18 years
  • New ischemic DFU <6 months
  • English or Spanish speaking
  • Able to provide consent

Exclusion

Exclusion Criteria:

  • incarceration or institutionalization
  • unwillingness to participate in the PAI program

Study Design

Total Participants: 24
Treatment Group(s): 1
Primary Treatment: Peer counseling group
Phase:
Study Start date:
November 21, 2023
Estimated Completion Date:
January 30, 2025

Study Description

Of the estimated 30 million people in the U.S. with diabetes, 34% will develop a DFU in their lifetime, and 50% of those with a DFU have concurrent PAD. Foot ulceration, which precedes 80% of amputations in diabetics, is associated with impaired physical function, reduced quality of life, and increased risk of death. Moreover, PAD, DFU, and subsequent major amputations are unevenly patterned in terms of racial/ethnic, SES, health insurance, and geographic status. More specifically, Black and Hispanic adults with an ischemic DFU have a higher prevalence of amputation than their White counterparts. The mechanisms of these observed disparities in amputation, beyond disease severity and comorbidities, are complex. However, evidence indicates that ulcer care (including wound care, diabetic shoe, offloading, and recognizing warning signs) is a significant challenge for low-income patients with an ischemic DFU. In addition, our team and other researchers have demonstrated how psychological, interpersonal, social, and healthcare system-level barriers limit appropriate ulcer and foot care. Furthermore, our qualitative data demonstrates a high rate of psychological and interpersonal factors to diabetic foot care that cannot be ignored. Clearly, there is a compelling need for innovative methods to improve DFU care that are based on health equity that led to diverse support. To address this gap, we propose a patient-centered and culturally tailored Peer-Pal Intervention (PPI) that helps promote ulcer care in patients with a DFU, while minimizing the burden placed on system resources.

Connect with a study center

  • Rancho Los Amigos National Rehabilitation Center

    Downey, California 90242
    United States

    Active - Recruiting

  • University of Southern California

    Los Angeles, California 90033
    United States

    Active - Recruiting

  • Casa Colina Healthcare and Hospital

    Pomona, California 91767
    United States

    Active - Recruiting

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