Adapting Lifestyle Offloading for DFUs

Adapting a Lifestyle-based Offloading Intervention in Diabetic Foot Ulcers

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.

Study Overview

• Status: Recruiting
• Conditions: Diabetic Foot; Diabetic Foot Ulcer
• Intervention / Treatment: Behavioral: Lifestyle-based intervention by an occupational therapist

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Tze Woei Tan; Phone Number: 3234426835; Email: tze-woei.tan@med.usc.edu
• Study Contact Backup: Name: Jason Garcia; Phone Number: 3234426835; Email: jason.Garcia@med.usc.edu

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90033
      • Recruiting
      • University of Southern California
      • Contact: Stacey Schepens Niemiec, PhD; Phone Number: 323-442-2069; Email: schepens@usc.edu
      • Contact: Tze-Woei Tan; Phone Number: 323-442-6835; Email: tze-woei.tan@med.usc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• English speaking
• Age 21 years or older
• History of active DFU necessitating offloading
• Capacity to provide informed consent
• Access to telehealth (internet connection and equipment)
• Ability to walk independently or with an assistive device
• Self-reported life expectancy of more than one year

Exclusion Criteria:

• Self-reported deafness or blindness
• history of lower extremity amputation besides toes

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Lifestyle-based intervention by an occupational therapist; Participants with diabetic foot ulcers will be offered lifestyle-based treatment sessions over telemedicine for up to 8 sessions with a licensed occupational therapist.	Behavioral: Lifestyle-based intervention by an occupational therapist; Participants with diabetic foot ulcers will be offered lifestyle-based treatment sessions virtually for up to 8 sessions (~8 weeks) with a licensed occupational therapist.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient satisfaction (change from baseline)	Participants will fill out a general satisfaction survey, adapted from and comprising 18 items from a validated measure: Short-Form Patient Satisfaction Questionnaire (PSQ-18). The scale ranges from 1 (strongly agree) to 5 (strongly disagree).	Baseline and discharge from OT (3 to 8 weeks)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Offloading knowledge and attitudes (change from baseline)	Participants will complete 41 items of an offloading-specific knowledge and attitudes survey. This survey includes common factors known to influence healing of diabetic foot ulcers (e.g., history of ulcers, access to transportation) and assessment of a person's knowledge of good offloading practices and their attitudes toward those practices. Questions are mixed in style/format, including 5-point Likert (strongly disagree [1] to strongly agree [5]) items such as "My wound does not worry me because it is not painful", yes/no (e.g., "In the past I had a foot wound linked to my diabetes."), and short answer (e.g., "How do you get to the place where you receive treatment for your foot ulcer?"). There is no total score available. Change from baseline in the 27 Likert-scale questions will be assessed individually for each item.	Baseline and discharge from OT (3 to 8 weeks)
Frequency of DFU-related outcomes	Number of participants with various DFU-related outcomes including DFU healing, minor amputation, major amputation, and ulcer recurrence after healing as extracted from electronic medical record documentation 6 months post-enrollment to the intervention.	6-month post-enrollment
Diabetes distress (change from baseline)	Participants will complete the Type 2 Diabetes Distress Assessment System (T2D-DAS). The T2D-DAS is a validated, multidimensional self-report measure designed to assess diabetes-related distress in adults with type 2 diabetes. It includes 7 domain-specific sources of distress across key areas of diabetes self-management and psychosocial impact (i.e., 7 sources of distress including hypoglycemia, long-term health, health care provider, interpersonal issues, shame or stigma, health care access, and management demands). The T2D-DAS provides a comprehensive profile of diabetes distress. Each item is rated on a 5-point Likert scale ranging from 1 ("Not a problem") to 5 ("A very serious problem"). Subscale scores are calculated as the mean of items within each domain. Higher scores indicate greater diabetes distress.	Baseline and discharge from OT (3 to 8 weeks)

Collaborators and Investigators

• Sponsor: University of Southern California

Study record dates

Study Major Dates

• Study Start (Actual): February 10, 2025
• Primary Completion (Estimated): April 1, 2026
• Study Completion (Estimated): April 1, 2026

Study Registration Dates

• First Submitted: February 16, 2024
• First Submitted That Met QC Criteria: February 16, 2024
• First Posted (Actual): February 26, 2024

Study Record Updates

• Last Update Posted (Actual): May 18, 2025
• Last Update Submitted That Met QC Criteria: May 13, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: Occupational therapy; Self management; Offloading diabetic foot ulcer; Lifestyle-focused intervention; Occupational therapist
• Additional Relevant MeSH Terms: Endocrine System Diseases; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Diabetes Mellitus; Diabetic Angiopathies; Diabetes Complications; Skin Diseases; Skin Ulcer; Leg Ulcer; Diabetic Neuropathies; Foot Diseases; Ulcer; Diabetic Foot; Foot Ulcer
• Other Study ID Numbers: APP-24-00887

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No