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NCT06278935 Clinical Trial

Lifestyle Tailored Offloading for Diabetic Foot Ulcers

Diabetic Foot Ulcer Clinical Trial

Official title:
Adapting a Lifestyle-based Offloading Intervention in Diabetic Foot Ulcers

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT06278935
Other study ID # APP-24-00887
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date April 2024
Est. completion date April 2026

Study information
Verified date March 2024
Source University of Southern California
Contact Tze Woei Tan
Phone 3234426835
Email tze-woei.tan@med.usc.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The goal of this pilot clinical trial is to develop and test a tailored occupational therapist-led lifestyle-focused intervention to aid patients in improving diabetic foot ulcer care. The main questions it aims to answer are to determine the acceptability and feasibility of taking a tailored lifestyle-focused approach as part of comprehensive diabetic foot ulcer management. Patient participants with DFUs who require offloading treatment will receive the tailored lifestyle-focused self-management intervention.

Description:

Diabetic foot ulcers (DFUs) frequently lead to major amputation and mortality. While relieving foot pressure (i.e., offloading) is vital for healing, many patients struggle to adhere to recommended offloading treatments. Participants with DFUs who require offloading treatment will receive the tailored lifestyle-focused self-management intervention. This occupational therapist-led lifestyle-focused intervention will be co-developed with participants, caregivers, family members, and DFU care team members. Participants with DFUs will be offered lifestyle-based treatment sessions for up to 8 weeks (virtually) with a licensed occupational therapist. Participants will complete pre/post surveys and a subset will take part in an interview to clarify key findings from surveys and obtain patients' perspective of the effectiveness of the intervention. Investigators will also offer focus group interviews to the DFU care team members and occupational therapist to learn their perceptions on the intervention's acceptability, appropriateness, efficiency, and feasibility at the conclusion of the intervention.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 80
Est. completion date April 2026
Est. primary completion date April 2026
Accepts healthy volunteers No
Gender All
Age group 21 Years and older
Eligibility Inclusion Criteria: - English or Spanish speaking - Age 21 years or older - History of active DFU necessitating offloading - Capacity to provide informed consent - Access to tele-health (internet connection and equipment) - Ability to walk independently - Self-reported life expectancy of more than one year Exclusion Criteria: - Self-reported deafness or blindness

Study Design

Related Conditions & MeSH terms

Intervention

Behavioral:
• Lifestyle-based intervention by a occupational therapist
Participants with diabetic foot ulcers will be offered lifestyle-based treatment sessions virtually for up to 8 weeks with a licensed occupational therapist.

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
University of Southern California

Outcome
Type Measure Description Time frame Safety issue
Primary Participant satisfaction Participants will fill out a general satisfaction survey, comprising 18 items from a validated measures: Short-Form Patient Satisfaction Questionnaire (PSQ-18). The scale ranges from 1 (strongly agree) to 5 (strongly disagree). 6-month
Secondary Diabetes distress Participants will complete the Diabetes Distress Scale-17 (DDS-17), a 17-item self-report instrument is rated on a 6-point scale, ranges from 1 (not a problem) to 6 (a very significant problem). 6-month
Secondary Factors affecting offloading treatment Participants will complete 41 items offloading-specific knowledge and attitudes survey. 6-month
Secondary DFU-related outcomes Number of participants with DFU healing, minor amputation, major amputation, and ulcer recurrence after healing. 6-month
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