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.
Diabetic foot ulcers (DFUs) are a significant complication of diabetes, responsible for 80% of lower extremity amputations in the United States and posing a substantial burden on patients and society. Despite treatment, up to 23% of DFUs remain unhealed at 12 months, with recurrence rates of 40% within a year and 65% within three years. Proper offloading of foot pressure and glucose control is crucial for preventing recurrent DFUs, especially in cases of neuropathy. While standard clinical practice includes patient education and therapeutic footwear prescription, adherence to offloading treatment often falls short due to non-medical factors such as insufficient understanding and difficulties integrating offloading into daily routines. To tackle these challenges, we propose a lifestyle-focused intervention, conducted by trained occupational therapist (OT), aiming at fostering consistent self-care habits and routines.The objective of this pilot trial is to evaluate the feasibility acceptability of a lifestyle-focused OT intervention for enhancing offloading treatment in high-risk individuals with a history of healed DFUs.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
60
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.
Rancho Los Amigos National Rehabilitation Center
Downey, California, United States
NOT_YET_RECRUITINGKeck Hospital of USC
Los Angeles, California, United States
RECRUITINGLos Angeles General Medical Center
Los Angeles, California, United States
RECRUITINGNumbers 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.
Time frame: 6-month
Numbers of participants with diabetic foot ulcer recurrence
Rates of foot ulcer recurrence and any amputation.
Time frame: 6-month
Numbers of participants who report satisfaction with the program
Participants will complete the Short-form Patient Satisfaction Questionnaire (PSQ-18). The 18 items' scale ranges from 1 (strong agree) to 5 (strongly disagree). Selected participants will be invited to participate in semi-structured interviews.
Time frame: 6-month
Number of participants with diabetes distress
Participants will complete the Diabetes Distress Scale (DDS), a 17-item self-report instrument. Each item is rated on a 6-point scale from 1 (not a problem) to 6 (a very significant problem.
Time frame: 6-month
Participant's Quality of Life
Participants will complete the Patient-Reported Outcomes Measurement Information System (PROMIS) that evaluate physical, mental, and social health.
Time frame: 6-month
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