Adapting Lifestyle Offloading for DFUs

NCT06278935 | Recruiting

• 1 other identifier: APP-24-00887
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Diabetic Foot Ulcer; Diabetic Foot

Keywords

Offloading diabetic foot ulcer; Lifestyle-focused intervention; Occupational therapy; Occupational therapist; Self management

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Diabetes distress (change from baseline)

  Baseline and discharge from OT (3 to 8 weeks)

• Offloading knowledge and attitudes (change from baseline)

  Baseline and discharge from OT (3 to 8 weeks)

• Frequency of DFU-related outcomes

  6-month post-enrollment

Study Arms (1)

Lifestyle-based intervention by an occupational therapist

EXPERIMENTAL

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

Interventions

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.

Lifestyle-based intervention by an occupational therapist

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Southern California: lead

Study Sites (1)

University of Southern California

Los Angeles, California, 90033, United States

RECRUITING

MeSH Terms

Conditions

Diabetic Foot

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies

Central Study Contacts

Tze Woei Tan

CONTACT

3234426835; tze-woei.tan@med.usc.edu

Jason Garcia

CONTACT

3234426835; jason.Garcia@med.usc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Clinical Surgery

Study Record Dates

• First Submitted: February 16, 2024
• First Posted: February 26, 2024
• Study Start: February 10, 2025
• Primary Completion: April 1, 2026
• Study Completion: April 1, 2026
• Last Updated: May 18, 2025

Record last verified: 2025-05

Locations

US (1)