Lifestyle Intervention for Diabetic Foot Ulcers

Recruiting at 2 trial locations

Overseen By Elaine Wong

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Southern California

Disqualifiers: Active foot ulcer, Amputation, Non-ambulatory, Deafness, Blindness

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a lifestyle program can help people with diabetes prevent the recurrence of foot ulcers. The goal is to assist participants in developing daily habits to consistently wear special shoes and care for their feet. One group will participate in telemedicine sessions with occupational therapists as part of a Lifestyle-focused Occupational Therapy Intervention, while another will receive standard education on foot care. Individuals who had a healed diabetic foot ulcer in the past year and can walk independently may be suitable candidates for this study. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could enhance daily life for people with diabetes.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this lifestyle-focused occupational therapy intervention is safe?

Research has shown that lifestyle-focused occupational therapy for diabetic foot ulcers has been safe in past studies. A 12-week exercise program, developed with input from doctors, nurses, and patients, proved to be safe. These programs aim to help people with diabetes manage daily routines, such as wearing special shoes. No major side effects have been reported, indicating that the treatment is well-tolerated. This suggests the therapy is a safe option for preventing the recurrence of foot ulcers. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Lifestyle-focused Occupational Therapy (OT) Intervention for diabetic foot ulcers because it emphasizes telemedicine sessions with trained occupational therapists. Unlike the standard care options, which typically involve in-person education on foot self-care and offloading techniques, this intervention provides personalized, remote support. This approach not only increases accessibility for participants who may struggle to attend in-person sessions but also aims to integrate lifestyle changes more seamlessly into daily routines, potentially leading to better long-term outcomes in managing and preventing diabetic foot ulcers.

What evidence suggests that this lifestyle-focused occupational therapy intervention is effective for preventing diabetic foot ulcers?

This trial will compare a Lifestyle-focused Occupational Therapy (OT) Intervention with standard education on foot self-care. Research has shown that lifestyle changes through occupational therapy can help prevent the recurrence of diabetic foot ulcers. Studies have found that collaborating with occupational therapists to establish daily routines aids individuals in consistently wearing special shoes that reduce foot pressure. This therapy supports individuals in maintaining these routines, which is crucial for preventing ulcers from returning. Additionally, reviews of multiple studies have found that lifestyle changes can significantly lower the risk of ulcer recurrence in people with diabetes. Overall, this approach is promising because it helps individuals take better care of their feet and manage their diabetes more effectively. ^{1 2 3 4 5}

Who Is on the Research Team?

Tze Woei Tan

Principal Investigator

University of Southern California

Are You a Good Fit for This Trial?

This trial is for individuals with diabetes who have previously had foot ulcers. Participants should be interested in learning how to prevent future ulcers through lifestyle changes and are willing to follow a treatment plan that includes using special shoes designed to reduce foot pressure.

Inclusion Criteria

I had a diabetic foot ulcer that healed in the last year.

I can walk on my own, but I may use a cane.

I am 21 years old or older.

Exclusion Criteria

I have an active foot ulcer due to diabetes.

I have had an amputation other than a toe or part of the foot.

I cannot walk by myself.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage in a lifestyle-focused occupational therapy intervention or receive standard education on foot self-care and offloading treatment

6 months

Telemedicine sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of diabetes distress, foot ulcer recurrence, and quality of life

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Lifestyle-focused Occupational Therapy Intervention

Trial Overview The study tests if a program focused on daily routines and habits can help people consistently use therapeutic footwear and manage their diabetes better, aiming to prevent the recurrence of diabetic foot ulcers.

How Is the Trial Designed?

Group I: Lifestyle-focused Occupational Therapy (OT) Intervention Experimental Treatment 1 Intervention

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

Group II: Education Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

University of Southern California

Lead Sponsor

Trials

956

Recruited

1,609,000+

Published Research Related to This Trial

In a study of 449 patients with diabetic foot ulcers, 65.7% of ulcers healed without amputation within 12 months, but only 45% of patients were alive, ulcer-free, and without amputation at the same time point, highlighting a significant gap between ulcer healing and overall patient health outcomes.

The findings suggest that focusing solely on ulcer-related outcomes may underestimate the true morbidity and mortality associated with diabetic foot disease, indicating a need for greater emphasis on patient-related outcomes in evaluating treatment effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessing the outcome of the management of diabetic foot ulcers using ulcer-related and person-related measures. Jeffcoate, WJ., Chipchase, SY., Ince, P., et al.[2022]

Individuals at risk of diabetic foot ulcers face unique challenges that can hinder their ability to increase physical activity, including concerns about pain, depression, and self-efficacy.

Despite these challenges, physical activity is not contraindicated for at-risk patients, and the review provides recommendations for safely implementing exercise interventions to help reduce the risk of foot ulcers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physiological and psychological challenges of increasing physical activity and exercise in patients at risk of diabetic foot ulcers: a critical review. Crews, RT., Schneider, KL., Yalla, SV., et al.[2018]

Citations

1. reporter.nih.gov reporter.nih.gov/project-details/11112541

Project Details The lifestyle-focused OT intervention is expected to be feasible and acceptable to patients and providers in DFU prevention. It may improve adherence to ...

2. withpower.com withpower.com/trial/phase-foot-ulcer-8-2024-7f4fa

Lifestyle Intervention for Diabetic Foot Ulcers 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 ...

3. chan.usc.edu chan.usc.edu/research/projects/developing-a-lifestyle-focused-self-management-intervention-for-diabetic-foot-ulcers-offloading

Developing a lifestyle-focused self-management intervention ... Developing a lifestyle-focused self-management intervention for diabetic foot ulcers offloading. The aims of this study are to co-develop a lifestyle-based ...

4. iwgdfguidelines.org iwgdfguidelines.org/wp-content/uploads/2020/03/van-Netten_et_al-2020-IWGDF-prevention-systematic-review.pdf

Prevention of foot ulcers in the at‐risk patient with diabetes Abstract. Prevention of foot ulcers in patients with diabetes is important to help reduce the substantial burden on both patient and health resources.

5. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/full/10.1002/dmrr.3652

Prevention of foot ulcers in persons with diabetes at risk ... The aim of this systematic review and meta-analysis is to assess the effectiveness of interventions to prevent foot ulcers in persons with diabetes who are at ...