Evaluating the Feasibility and Acceptability of a Lifestyle Intervention to Prevent Recurrence of Diabetic Foot Ulcers: A Pilot Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Diabetic Foot
- Sponsor
- University of Southern California
- Enrollment
- 60
- Locations
- 3
- Primary Endpoint
- Numbers of participants who have completed the study
- Status
- Recruiting
- Last Updated
- 10 months ago
Overview
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.
Investigators
Tze-Woei Tan
Associate Professor of Clinical Surgery
University of Southern California
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Numbers of participants who have completed the study
Time Frame: 6-month
Investigators will measure participant attendance, completion of planned/scheduled sessions, retention of participants in the intervention and education (control) groups.
Secondary Outcomes
- Numbers of participants with diabetic foot ulcer recurrence(6-month)
- Number of participants with diabetes distress(6-month)
- Numbers of participants who report satisfaction with the program(6-month)
- Participant's Quality of Life(6-month)