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
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 2024
• Est. completion date: April 2026

Study information

• Verified date: June 2024
• Source: University of Southern California
• Contact: Tze Woei Tan
• Phone: 3234426835
• Email: tze-woei.tan[@]med.usc.edu
• Is FDA regulated: No
• 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

Related Conditions & MeSH terms

• Diabetic Foot
• Diabetic Foot Ulcer
• Foot Ulcer
• Ulcer

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