Ignite Creation Date:
2024-05-06 @ 7:26 PM
Last Modification Date:
2024-10-26 @ 3:06 PM
Study NCT ID:
NCT06004219
Status:
RECRUITING
Last Update Posted:
2023-12-06
First Post:
2023-06-30
Brief Title:
Peer Support for Patients With Diabetic Foot Ulcers
Sponsor:
Casa Colina Hospital and Centers for Healthcare
Organization:
Casa Colina Hospital and Centers for Healthcare
Study Overview
Official Title:
Peer Support in Patients With Diabetic Foot Ulceration
Status:
RECRUITING
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 DFUDiabetes peripheral arterial disease PAD foot ulceration and subsequent amputation are unevenly patterned in terms of racialethnicity socioeconomic status health insurance and geographic area The project will identify opportunities to reduce health disparities among economically marginalized patients regarding DFU outcomes
Detailed Description:
Of the estimated 30 million people in the US 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 racialethnic 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None