Evaluating a Lifestyle Intervention to Prevent Recurrence of Diabetic Foot Ulcers
Evaluating the Feasibility and Acceptability of a Lifestyle Intervention to Prevent Recurrence of Diabetic Foot Ulcers: A Pilot Study
1 other identifier
interventional
60
1 country
3
Brief Summary
People with diabetes often experience foot ulcers, which can harm their ability to move, lower their quality of life, and increase the chances of losing a limb. These diabetic foot ulcers (DFUs) commonly come back (recur) even after they've healed, so it's crucial to stop them from returning to avoid toe, foot , or leg amputation. While wearing special shoes to reduce pressure on the feet is essential for healing and preventing DFUs, many people struggle to follow this treatment plan once their ulcers have healed. This study aims to see if a lifestyle-focused program can help participants create daily routines and habits that make it easier to consistently use special shoes and take care of their diabetes and feet to prevent ulcers from recurring.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jun 2025
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 27, 2024
CompletedFirst Posted
Study publicly available on registry
July 5, 2024
CompletedStudy Start
First participant enrolled
June 11, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 30, 2026
June 22, 2025
June 1, 2025
12 months
June 27, 2024
June 20, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Numbers of participants who have completed the study
Investigators will measure participant attendance, completion of planned/scheduled sessions, retention of participants in the intervention and education (control) groups.
6-month
Secondary Outcomes (4)
Numbers of participants with diabetic foot ulcer recurrence
6-month
Numbers of participants who report satisfaction with the program
6-month
Number of participants with diabetes distress
6-month
Participant's Quality of Life
6-month
Study Arms (2)
Lifestyle-focused Occupational Therapy (OT) Intervention
EXPERIMENTALParticipants in the intervention group will engage in telemedicine sessions led by trained occupational therapists.
Education
ACTIVE COMPARATORParticipants in the control group will receive standard education on foot self-care and offloading treatment aimed at preventing foot ulcer recurrence.
Interventions
The proposed intervention, led by trained occupational therapists, will focus on establishing sustainable self-care routines. It will consist of approximately 12 biweekly sessions, each lasting about an hour on average. Therapists will customize session timing and duration based on participant needs.
Participants in the education group will receive standardized education materials on diabetic foot ulcers (DFUs), foot care, and offloading treatment to prevent foot ulcer recurrence.
Eligibility Criteria
You may qualify if:
- Age \>= 21 years
- Healed diabetic foot ulcer within the past twelve months
- Able to walk independently (use of a cane is acceptable)
You may not qualify if:
- Current active diabetic foot ulcer
- History of amputation beside toe or part of the foot
- Non-ambulatory at baseline
- Self-reported deafness/blindness.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Rancho Los Amigos National Rehabilitation Center
Downey, California, 90242, United States
Keck Hospital of USC
Los Angeles, California, 90033, United States
Los Angeles General Medical Center
Los Angeles, California, 90033, United States
Related Publications (2)
Pyatak EA, Carandang K, Rice Collins C, Carlson M. Optimizing Occupations, Habits, and Routines for Health and Well-Being With Lifestyle Redesign(R): A Synthesis and Scoping Review. Am J Occup Ther. 2022 Sep 1;76(5):7605205050. doi: 10.5014/ajot.2022.049269.
PMID: 36053733BACKGROUNDPyatak EA, Carandang K, Vigen CLP, Blanchard J, Diaz J, Concha-Chavez A, Sequeira PA, Wood JR, Whittemore R, Spruijt-Metz D, Peters AL. Occupational Therapy Intervention Improves Glycemic Control and Quality of Life Among Young Adults With Diabetes: the Resilient, Empowered, Active Living with Diabetes (REAL Diabetes) Randomized Controlled Trial. Diabetes Care. 2018 Apr;41(4):696-704. doi: 10.2337/dc17-1634. Epub 2018 Jan 19.
PMID: 29351961BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Tze Woei Tan
University of Southern California
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor of Clinical Surgery
Study Record Dates
First Submitted
June 27, 2024
First Posted
July 5, 2024
Study Start
June 11, 2025
Primary Completion (Estimated)
June 1, 2026
Study Completion (Estimated)
June 30, 2026
Last Updated
June 22, 2025
Record last verified: 2025-06
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ANALYTIC CODE
- Time Frame
- Commencing 24 months after the award initiation, all data will be deposited onto USC-provided OneDrive, with subsequent deposits occurring every six months thereafter.
- Access Criteria
- Public
The investigators intend to share de-identified demographic, clinical, and survey data, along with qualitative data from interviews. This data will be stored in USC-provided OneDrive accounts, approved for Confidential Data storage according to USC standards. All de-identified scientific data, including raw/measured and derived data, will be preserved and shared to support reproducibility and reusability. Research results will be published in peer-reviewed scientific journals and presented at selected scientific meetings. Manuscripts accepted by journals without free access will be publicly available on Pubmed Central, in accordance with NIH guidelines for Sharing of Research Data.