Clinical trial NCT06004219: Peer Support for Patients With Diabetic Foot Ulcers
Official title: Peer Support in Patients With Diabetic Foot Ulceration
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Diabetic Foot Ulcer
Diabetic Wound
Diabetes Mellitus, Type 2
Diabetic Foot
Diabetes Complications
Peripheral Neuropathy
Keywords: numbness
tingling
muscle weakness
loss of balance
shooting pain
Lead sponsor: Casa Colina Hospital and Centers for Healthcare
Sponsor class: OTHER
Collaborators: name: University of Southern California
name: Vascular Cures
name: Department of Health and Human Services
name: Rancho Los Amigos National Rehabilitation Center
First posted: 2023-08-22
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: We will assign 12 patients into peer support group (intervention) and 12 patients as control (usual care with no support group) group. Patients will be followed for 6 months.
Primary purpose: SUPPORTIVE_CARE

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 (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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: VascuQoL-6
timeFrame: Complete at enrollment visit
measure: VascuQoL-6
timeFrame: Complete at 3 month visit
measure: VascuQoL-6
timeFrame: Complete at 6 month visit, end of study
measure: PROMIS (Patient Reported Outcomes Measurement Information System)
timeFrame: Complete at enrollment visit
measure: PROMIS (Patient Reported Outcomes Measurement Information System)
timeFrame: Complete at 3 month visit
measure: PROMIS (Patient Reported Outcomes Measurement Information System)
timeFrame: Complete at 6 month visit, end of study
measure: Acceptability Questionnaire --Peer to Pal Intervention (PPI)
timeFrame: End of study, 6 month visit
measure: Twenty Three Item Questionnaire (Heisler)
timeFrame: End of Study, 6 month visit
measure: Diabetes Distress Screening Scale (DDS17)
timeFrame: Complete at enrollment visit
measure: Diabetes Distress Screening Scale (DDS17)
timeFrame: Complete at 3 month visit
measure: Diabetes Distress Screening Scale (DDS17)
timeFrame: End of study, 6 month visit
Secondary outcomes:
Other outcomes:
Locations:
city: Downey
country: United States
facility: Rancho Los Amigos National Rehabilitation Center
state: California
city: Los Angeles
country: United States
facility: University of Southern California
state: California
city: Pomona
country: United States
facility: Casa Colina Healthcare and Hospital
state: California
Study officials:
affiliation: Casa Colina Hospital and Centers for Healthcare
name: Emily Rosario, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Armstrong DG, Boulton AJM, Bus SA. Diabetic Foot Ulcers and Their Recurrence. N Engl J Med. 2017 Jun 15;376(24):2367-2375. doi: 10.1056/NEJMra1615439. No abstract available.
citation: Hoffstad O, Mitra N, Walsh J, Margolis DJ. Diabetes, lower-extremity amputation, and death. Diabetes Care. 2015 Oct;38(10):1852-7. doi: 10.2337/dc15-0536. Epub 2015 Jul 22.
citation: Crocker RM, Palmer KNB, Marrero DG, Tan TW. Patient perspectives on the physical, psycho-social, and financial impacts of diabetic foot ulceration and amputation. J Diabetes Complications. 2021 Aug;35(8):107960. doi: 10.1016/j.jdiacomp.2021.107960. Epub 2021 May 23.