Evaluating a Lifestyle Intervention to Prevent Recurrence of Diabetic Foot Ulcers

University of Southern California

Status: Enrolling

Conditions: Foot Ulcer, Diabetic; Foot Wound; Diabetic Foot; Diabetic Foot Ulcer

Treatments: Other: Education; Behavioral: Lifestyle-focused Occupational Therapy Intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT06487780

APP-24-03267

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Lifestyle-focused Occupational Therapy (OT) Intervention

Experimental group

Description:

Participants in the intervention group will engage in telemedicine sessions led by trained occupational therapists.

Treatment:

Behavioral: Lifestyle-focused Occupational Therapy Intervention

Education

Active Comparator group

Description:

Participants in the control group will receive standard education on foot self-care and offloading treatment aimed at preventing foot ulcer recurrence.

Treatment:

Other: Education