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

Trial Summary

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 data supports the effectiveness of the treatment Lifestyle-focused Occupational Therapy Intervention for diabetic foot ulcers?

Research on telehealth Lifestyle Redesign occupational therapy, which is similar to the lifestyle-focused intervention, shows it can improve health management and satisfaction in people with diabetes. Additionally, occupational therapy has been shown to enhance diabetes self-management and quality of life, which may indirectly support its effectiveness for diabetic foot ulcers. ^{1 2 3 4 5}

Is the Lifestyle Intervention for Diabetic Foot Ulcers safe for humans?

The 12-week exercise therapy program for diabetic foot ulcers was developed with input from doctors, nurses, and patients, and was found to be safe for the three patients who participated, although more research is needed to confirm these findings. ^{1 6 7 8 9}

How does the Lifestyle-focused Occupational Therapy Intervention treatment differ from other treatments for diabetic foot ulcers?

The Lifestyle-focused Occupational Therapy Intervention is unique because it emphasizes lifestyle changes and occupational therapy to manage diabetic foot ulcers, unlike traditional treatments that may focus solely on medical or surgical interventions. This approach may include personalized strategies to improve daily activities and promote healing through lifestyle adjustments, which is different from standard care that often does not address these aspects. ^{1 6 10 11 12}

What is the purpose of this trial?

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.

Research Team

Tze Woei Tan

Principal Investigator

University of Southern California

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Effectiveness of psychosocial interventions for the prevention and treatment of foot ulcers in people with diabetes: a systematic review. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Assessing the outcome of the management of diabetic foot ulcers using ulcer-related and person-related measures. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Telehealth Lifestyle Redesign Occupational Therapy for Diabetes: Preliminary Effectiveness, Satisfaction, and Engagement. [2023]

4. Egypt pubmed.ncbi.nlm.nih.gov

The Role of Occupational Therapy in Secondary Prevention of Diabetes. [2020]

5. New Zealand pubmed.ncbi.nlm.nih.gov

Methodological considerations of investigating adherence to using offloading devices among people with diabetes. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

A 12-Week Supervised Exercise Therapy Program for Patients with Diabetic Foot Ulcers: Program Development and Preliminary Feasibility. [2023]

7. Netherlands pubmed.ncbi.nlm.nih.gov

The health status of diabetic patients receiving orthotic therapy. [2019]

8. England pubmed.ncbi.nlm.nih.gov

Intervention planning for the REDUCE maintenance intervention: a digital intervention to reduce reulceration risk among patients with a history of diabetic foot ulcers. [2021]

9. England pubmed.ncbi.nlm.nih.gov

Behaviour change approaches for individuals with diabetes to improve foot self-management: a scoping review. [2021]

10. England 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. [2018]

11. Egypt pubmed.ncbi.nlm.nih.gov

Effects of a Short Educational Program for the Prevention of Foot Ulcers in High-Risk Patients: A Randomized Controlled Trial. [2022]

12. Japan pubmed.ncbi.nlm.nih.gov

A 15-year follow-up report of an elderly diabetic foot with multiple recurrences leading to toe amputation and thoughts on the model of care for diabetic foot ulcer. [2023]