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Peer Support for Diabetic Foot Ulcers

N/A

Recruiting

Led By Emily Rosario, PhD

Research Sponsored by Casa Colina Hospital and Centers for Healthcare

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age >18 years

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up end of study, 6 month visit

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to reduce disparities in ulcer care for people with diabetes, PAD, and foot ulcers, especially those from disadvantaged economic backgrounds.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since the intervention involves peer counseling rather than medication, there are no direct medical side effects expected from participating in this trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am older than 18 years.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ end of study, 6 month visit

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~end of study, 6 month visit

This trial's timeline: 3 weeks for screening, Varies for treatment, and end of study, 6 month visit for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Acceptability Questionnaire --Peer to Pal Intervention (PPI)

Diabetes Distress Screening Scale (DDS17)

PROMIS (Patient Reported Outcomes Measurement Information System)

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Peer Support GroupExperimental Treatment1 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 GroupActive Control1 Intervention

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

0 / 1Eligibility criteria met