Recruiting

Observational Study

Sponsor:

Casa Colina Hospital and Centers for Healthcare

Code:

NCT06004219

Conditions

Diabetic Foot Ulcer

Diabetic Wound

Diabetes Mellitus, Type 2

Diabetic Foot

Diabetes Complications

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Peer counseling group

Study Details

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.

Conditions

Diabetic Foot Ulcer

Diabetic Wound

Diabetes Mellitus, Type 2

Diabetic Foot

Diabetes Complications

Study ID

NCT06004219

Start date

Nov 21, 2023

Status verified date

Dec, 2023

Completion date

Jan 30, 2025

Anticipated

Primary completion date

Oct, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

24 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Peer Support Group

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

no intervention: Usual Care Group

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

Interventions

Peer counseling group

A community advisory board (CAB) will be set up for need assessment and to design the peer support program. Virtual meetings will be held quarterly for year 1 and 2. The group will consist of (up to 12 members) and will include at least 2 patient partners (patients with a recently diagnosed ulcer), 2 peer pals (patients with a healed DFU), family members or caregivers (limited to only 1 person per family represented on the CAB), healthcare workers (podiatrist, nurse, or case manager), medical equipment company representatives, and others. We will ask them about potential barriers at the first meeting, have flexible meeting times, and intentionally limit the number of healthcare providers. At the last meeting, we will seek feedback and input from the CAB. In addition, this group will have the opportunity to participate in a focus group which will be moderated with a trained, bilingual assistant and will last 40-60 minutes.

Primary outcome measure

  • VascuQoL-6 [ Time Frame: Complete at enrollment visit ]
  • VascuQoL-6 [ Time Frame: Complete at 3 month visit ]
  • VascuQoL-6 [ Time Frame: Complete at 6 month visit, end of study ]
  • PROMIS (Patient Reported Outcomes Measurement Information System) [ Time Frame: Complete at enrollment visit ]
  • PROMIS (Patient Reported Outcomes Measurement Information System) [ Time Frame: Complete at 3 month visit ]
  • PROMIS (Patient Reported Outcomes Measurement Information System) [ Time Frame: Complete at 6 month visit, end of study ]
  • Acceptability Questionnaire --Peer to Pal Intervention (PPI) [ Time Frame: End of study, 6 month visit ]
  • Twenty Three Item Questionnaire (Heisler) [ Time Frame: End of Study, 6 month visit ]
  • Diabetes Distress Screening Scale (DDS17) [ Time Frame: Complete at enrollment visit ]
  • Diabetes Distress Screening Scale (DDS17) [ Time Frame: Complete at 3 month visit ]
  • Diabetes Distress Screening Scale (DDS17) [ Time Frame: End of study, 6 month visit ]

Central Contacts and Locations

Central contacts

Niko Fullmer

909-596-7733nfullmer@casacolina.org

Locations

Rancho Los Amigos National Rehabilitation Center

Recruiting

Downey, California, United States, 90242

Contacts

Tze-Woei Tan, MD

323-442-6835Tze-woei.tan@med.usc.edu

University of Southern California

Recruiting

Los Angeles, California, United States, 90033

Contacts

Tze-Woei Tan, MD

323-442-6835Tze-woei.tan@med.usc.edu

Principal Investigator:

Tze-Woei Tan

Casa Colina Healthcare and Hospital

Recruiting

Pomona, California, United States, 91767

Contacts

Emily Rosario, PhD

909-596-7733erosario@casacolina.org

Principal Investigator:

Emily Rosario, PhD

More Information

Sponsor

Casa Colina Hospital and Centers for Healthcare

Last update posted

Dec 6, 2023

Last verified

Dec, 2023

Keywords

  • numbness
  • tingling
  • muscle weakness
  • loss of balance
  • shooting pain

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Casa Colina Hospital and Centers for Healthcare on 2023-12-06.