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NCT Number: NCT06278935

Adapting Lifestyle Offloading for DFUs

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.

Recruiting

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Key information

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lifestyle-based intervention by an occupational therapist

Behavioral

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.

Primary outcomes

  1. Patient satisfaction (change from baseline)

    Time frame: Baseline and discharge from OT (3 to 8 weeks)

    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).

Secondary outcomes

  1. Diabetes distress (change from baseline)

    Time frame: Baseline and discharge from OT (3 to 8 weeks)

    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.

  2. Offloading knowledge and attitudes (change from baseline)

    Time frame: Baseline and discharge from OT (3 to 8 weeks)

    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.

  3. Frequency of DFU-related outcomes

    Time frame: 6-month post-enrollment

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Jason Garcia

CONTACT

[email protected]

3234426835

Tze Woei Tan

CONTACT

[email protected]

3234426835

Sponsors and collaborators

Lead sponsor

University of Southern California

Other

Registry information

Official study title

Adapting a Lifestyle-based Offloading Intervention in Diabetic Foot Ulcers

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Feb 26, 2024
Registry last updated
May 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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