Diabetic Foot, Diabetic Foot Ulcer, Foot Ulcer, Diabetic, Foot Wound
Conditions
Keywords
Diabetic foot ulcer, lifestyle intervention
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.
Detailed description
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.
Interventions
BEHAVIORALLifestyle-focused Occupational Therapy Intervention
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.
OTHEREducation
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.
Sponsors
University of Southern California
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
Participants will be randomly assigned to one of two groups, with an equal number in each group.
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age \>= 21 years * Healed diabetic foot ulcer within the past twelve months * Able to walk independently (use of a cane is acceptable)
Exclusion criteria
* Current active diabetic foot ulcer * History of amputation beside toe or part of the foot * Non-ambulatory at baseline * Self-reported deafness/blindness.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Numbers of participants who have completed the study | 6-month | Investigators will measure participant attendance, completion of planned/scheduled sessions, retention of participants in the intervention and education (control) groups. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Numbers of participants with diabetic foot ulcer recurrence | 6-month | Rates of foot ulcer recurrence and any amputation. |
| Numbers of participants who report satisfaction with the program | 6-month | 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. |
| Number of participants with diabetes distress | 6-month | 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. |
| Participant's Quality of Life | 6-month | Participants will complete the Patient-Reported Outcomes Measurement Information System (PROMIS) that evaluate physical, mental, and social health. |
Countries
United States
Contacts
Primary ContactTze-Woei Tan, MD
Backup ContactElaine Wong
Outcome results
None listed