Clinical trial NCT06487780: Evaluating a Lifestyle Intervention to Prevent Recurrence of Diabetic Foot Ulcers
Official title: Evaluating the Feasibility and Acceptability of a Lifestyle Intervention to Prevent Recurrence of Diabetic Foot Ulcers: A Pilot Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Diabetic Foot
Diabetic Foot Ulcer
Foot Ulcer, Diabetic
Foot Wound
Keywords: Diabetic foot ulcer, lifestyle intervention
Lead sponsor: University of Southern California
Sponsor class: OTHER
First posted: 2024-07-05
Enrollment: 60
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomly assigned to one of two groups, with an equal number in each group.
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Numbers of participants who have completed the study
timeFrame: 6-month
Secondary outcomes:
measure: Numbers of participants with diabetic foot ulcer recurrence
timeFrame: 6-month
measure: Numbers of participants who report satisfaction with the program
timeFrame: 6-month
measure: Number of participants with diabetes distress
timeFrame: 6-month
measure: Participant's Quality of Life
timeFrame: 6-month
Other outcomes:
Locations:
city: Downey
country: United States
facility: Rancho Los Amigos National Rehabilitation Center
state: California
city: Los Angeles
country: United States
facility: Keck Hospital of USC
state: California
city: Los Angeles
country: United States
facility: Los Angeles General Medical Center
state: California
Study officials:
affiliation: University of Southern California
name: Tze Woei Tan
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Pyatak 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.