Evaluating a Lifestyle Intervention to Prevent Recurrence of Diabetic Foot Ulcers

NCT ID: NCT06487780

Last Updated: 2025-06-22

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-11
• Study Completion Date: 2026-06-30

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.

Conditions

Diabetic Foot; Diabetic Foot Ulcer; Foot Ulcer, Diabetic; Foot Wound

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Lifestyle-focused Occupational Therapy (OT) Intervention

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

Group Type: EXPERIMENTAL

Lifestyle-focused Occupational Therapy Intervention

Intervention Type: BEHAVIORAL

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.

Education

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

Group Type: ACTIVE_COMPARATOR

Education

Intervention Type: OTHER

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.

Interventions

Lifestyle-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.

Intervention Type: BEHAVIORAL

Education

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.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Southern California

OTHER

Sponsor Role: lead

Responsible Party

Tze-Woei Tan

Associate Professor of Clinical Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Tze Woei Tan

Role: PRINCIPAL_INVESTIGATOR

University of Southern California

Locations

Rancho Los Amigos National Rehabilitation Center

Downey, California, United States

Site Status: NOT_YET_RECRUITING

Keck Hospital of USC

Los Angeles, California, United States

Site Status: RECRUITING

Los Angeles General Medical Center

Los Angeles, California, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Tze-Woei Tan, MD

Role: CONTACT

tze-woei.tan@med.usc.edu

3234426835

Elaine Wong

Role: CONTACT

wongelai@usc.edu

3234426835

Facility Contacts

Tze Woei Tan

Role: primary

Tze-Woei Tan

Role: primary

Tze-Woei Tan

Role: primary

References

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.

Reference Type: BACKGROUND

PMID: 36053733 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 29351961 (View on PubMed)

Other Identifiers

APP-24-03267

Identifier Type: -

Identifier Source: org_study_id