Evaluating a Lifestyle Intervention to Prevent Recurrence of Diabetic Foot Ulcers

Not Applicable

Recruiting

• Conditions: Foot Wound; Diabetic Foot; Diabetic Foot Ulcer; Foot Ulcer, Diabetic
• Interventions: Other: Education; Behavioral: Lifestyle-focused Occupational Therapy Intervention

• Registration Number: NCT06487780
• Lead Sponsor: University of Southern California

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.

Study Timeline

• Study First Submitted: 2024-06-27
• Study First Submitted QC: 2024-06-27
• Study First Posted: 2024-07-05
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-12
• Last Update Posted: 2025-05-15
• Study Start: 2025-05-31
• Primary Completion: 2026-06-01
• Study Completion: 2026-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Education	Education	Participants in the control group will receive standard education on foot self-care and offloading treatment aimed at preventing foot ulcer recurrence.
Lifestyle-focused Occupational Therapy (OT) Intervention	Lifestyle-focused Occupational Therapy Intervention	Participants in the intervention group will engage in telemedicine sessions led by trained occupational therapists.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Numbers of participants with diabetic foot ulcer recurrence	6-month	Rates of foot ulcer recurrence and any amputation.
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.
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.
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.

Trial Locations

Locations (3)

Rancho Los Amigos National Rehabilitation Center; 🇺🇸 Downey, California, United States

Keck Hospital of USC; 🇺🇸 Los Angeles, California, United States

Los Angeles General Medical Center; 🇺🇸 Los Angeles, California, United States