Smart Boot for Diabetic Foot Ulcers

Recruiting at 3 trial locations

Overseen By Bijan Najafi, PHD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: University of Southern California

Disqualifiers: Wound duration, HbA1c, ABI, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

210 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests different types of boots to help people with diabetes heal foot ulcers, which are painful sores that can lead to serious complications if untreated. The study compares three kinds of boots: one that can't be removed, a removable one with counseling, and a "smart" removable boot (Smart Boot) that provides feedback via a smartwatch and smartphone. Researchers aim to determine which boot helps people adhere to their treatment plan and heals their sores more effectively. They will also assess how the boots affect physical activity, sleep, and quality of life. People with diabetes who have foot ulcers and require special shoes might be suitable for this trial. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of participants.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on testing different types of diabetic boots, so it's likely you can continue your current medications, but you should confirm with the trial organizers.

What prior data suggests that this smart boot is safe for diabetic foot ulcers?

Research shows that smart boots, like those under study, help people with diabetic foot ulcers heal by ensuring they wear the boot as directed. These smart boots use technology to track and encourage proper use. Previous studies on similar smart systems found that patients generally tolerate them well. No major safety issues have been reported, and the technology helps people follow their doctor's instructions, which is important for healing. Since this trial is in an early stage, it focuses on assessing the safety and ease of use of the boots. This suggests that the boots are expected to be safe, but more data will help confirm this. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the Smart Boot for diabetic foot ulcers because it introduces a novel approach to wound management through technology integration. Unlike traditional options like offloading devices or total contact casts, the Smart Boot incorporates elements like remote monitoring and adherence reinforcement via smartwatches and smartphones. These features aim to improve patient compliance and healing outcomes by ensuring the boot is worn consistently and correctly. With options for removable and irremovable versions, the Smart Boot offers flexibility for patient needs while maintaining focus on adherence, potentially leading to more effective ulcer healing.

What evidence suggests that this trial's smart boots could be effective for diabetic foot ulcers?

Research has shown that the smart boot designed for diabetic foot ulcers (DFUs) can improve adherence to boot-wearing instructions. In this trial, participants may receive one of several versions of the smart boot. The boot uses technology to provide real-time feedback on correct usage, which aids in faster wound healing. Some versions of the smart boot system can remotely monitor patients and report on their activity and adherence. This feedback helps patients stay on track and may accelerate healing. Early findings suggest that this method could be more effective than traditional methods lacking real-time monitoring and feedback. ^{1 2 3 4 6}

Who Is on the Research Team?

David G Armstrong, DPN, MD, PhD

Principal Investigator

Professor of Surgery, Keck School of Medicine of USC

Are You a Good Fit for This Trial?

This trial is for adults with diabetic foot ulcers needing offloading. Participants must be able to consent and attend clinic visits, but can't join if they have long-standing wounds, very high HbA1c levels (>12%), poor blood flow in the limbs, bone/tendon-involved ulcers, non-diabetic ulcers or are wheelchair-bound.

Inclusion Criteria

Able to provide written informed consent

I have a diabetic foot ulcer that needs pressure relief.

Exclusion Criteria

My blood flow in the legs is low, indicated by an ABI test result of less than 0.9.

I have had a wound for over a year.

Your HbA1c level is higher than 12%.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are assigned to one of three groups to wear different types of diabetic boots for 12 weeks, with monitoring of adherence and physical activity.

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, including wound healing and quality of life assessments.

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Counseling
• Smart Boot

Trial Overview

The study compares three types of diabetic boots: a non-removable boot, a removable boot with adherence counseling, and a 'smart' boot that gives feedback via smart devices. It aims to see which helps patients follow wearing instructions best and improve healing.

How Is the Trial Designed?

Group I: Group 3: SmartBoot Experimental Treatment 1 Intervention

The SmartBoot group follows a similar protocol to the control group, but adherence to wearing offloading during weight-bearing activities is reinforced using a smartwatch. The smartwatch provides real-time reminders when participants walk without the offloading device. In addition, data from remote patient monitoring may help personalize education during weekly clinic visits conducted by the research coordinator.

Group II: Group 1: Reference Group Active Control 1 Intervention

The group 1 will receive above-standard of care intervention, which includes wearing a standard removable boot and enhanced eductaion with weekly adherence reinforcement. In this group, participants are interviewed weekly, adherence is reviewed, and education is reinforced at each visit. Participants are instructed to wear the offloading device at all times, including during rest and at night, and not to remove it at any time.

Group III: Group 2: Control Group Active Control 1 Intervention

The control group uses removable offloading and represents the standard of care. These participants receive education at baseline and are advised to wear the offloading device during walking or standing; however, they are allowed to remove it during rest and sleep.

Smart Boot is already approved in United States for the following indications:

Approved in United States as Smart Boot for:

• Diabetic foot ulcers
• Neuropathic foot ulcers

Who Is Running the Clinical Trial?

University of Southern California

Lead Sponsor

Trials

956

Recruited

1,609,000+

University of California, Los Angeles

Collaborator

Trials

1,594

Recruited

10,430,000+

Baylor College of Medicine

Collaborator

Trials

1,044

Recruited

6,031,000+

Published Research Related to This Trial

Participants with diabetic foot ulcers (DFUs) found the smart removable walker (smart boot) easy to use and reported a strong preference for it, especially among Hispanic or Latino users, indicating that user-friendly designs can enhance adherence to treatment.

Non-fallers expressed a greater desire to wear the smart boot longer and found it easier to manage, suggesting that addressing user experience and comfort can improve compliance with offloading devices for ulcer healing.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Taking a Load Off: User Perceptions of Smart Offloading Walkers for Diabetic Foot Ulcers Using the Technology Acceptance Model. Finco, MG., Cay, G., Lee, M., et al.[2023]

Diabetes-related foot disease (DFD) is a major cause of disability, with about 50% of patients experiencing a recurrence within a year, highlighting the need for effective long-term management strategies.

Remote monitoring technologies, such as sensors for foot temperature and continuous glucose monitoring, show promise in preventing DFD by allowing for timely interventions and reducing the need for in-person consultations, although further research is needed to develop a comprehensive management program.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Potential Role of Sensors, Wearables and Telehealth in the Remote Management of Diabetes-Related Foot Disease. Golledge, J., Fernando, M., Lazzarini, P., et al.[2023]

In a study of 132 participants with diabetes and a history of foot ulcers, a remote foot-temperature monitoring system accurately predicted 97% of impending diabetic foot ulcers (DFUs) at a temperature asymmetry threshold of 2.22°C, providing an average lead time of 37 days.

The system was widely used, with 86% of participants using it at least 3 days a week, suggesting that it could significantly reduce the risk of DFUs and associated complications in patients with diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility and Efficacy of a Smart Mat Technology to Predict Development of Diabetic Plantar Ulcers. Frykberg, RG., Gordon, IL., Reyzelman, AM., et al.[2022]

Diabetes affects 422 million people globally, with many at risk for diabetic foot ulcers due to factors like peripheral neuropathy and poor blood flow, highlighting the need for better prevention strategies rather than just treatment of existing conditions.

The review emphasizes the potential of wearable and digital health technologies to monitor risk factors, empower patient self-care, and facilitate remote management of diabetic foot ulcers, which could significantly reduce hospital admissions and improve outcomes for at-risk individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Harnessing Digital Health Technologies to Remotely Manage Diabetic Foot Syndrome: A Narrative Review. Najafi, B., Mishra, R.[2022]

The SmartBoot, a smart offloading device for diabetic foot ulcers, demonstrated high accuracy in monitoring patient adherence with an average accuracy of 89.3%, which is crucial for effective healing.

Participants showed improved balance while using the SmartBoot, suggesting that it provides beneficial somatosensory feedback, and most users found it comfortable and easy to use, indicating its potential for clinical application.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Smart Offloading Boot System for Remote Patient Monitoring: Toward Adherence Reinforcement and Proper Physical Activity Prescription for Diabetic Foot Ulcer Patients. Park, C., Mishra, R., Vigano, D., et al.[2023]

The innovative intelligent insole system significantly reduced the incidence of diabetic foot ulcers by 71% over 18 months in high-risk patients compared to a control group, demonstrating its efficacy in preventing ulcer recurrence.

In patients who complied well with the system, the reduction in ulcer incidence was even greater at 86%, highlighting the potential of continuous plantar pressure monitoring and dynamic offloading guidance in managing diabetic foot health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Innovative intelligent insole system reduces diabetic foot ulcer recurrence at plantar sites: a prospective, randomised, proof-of-concept study. Abbott, CA., Chatwin, KE., Foden, P., et al.[2021]

Smart wearable devices, particularly insole systems and smart socks, are generally perceived as comfortable and useful for preventing diabetic foot ulcers (DFUs), but their acceptance is hindered by design issues and malfunctions reported by users.

Both patients and podiatrists expressed a need for improvements in device design before they would consider adopting these technologies, highlighting that user experience significantly influences the willingness to use and recommend these devices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient and Provider Perspective of Smart Wearable Technology in Diabetic Foot Ulcer Prevention: A Systematic Review. Orlando, G., Prior, Y., Reeves, ND., et al.[2021]

The novel spring-loaded walker boot significantly offloaded nearly 50% of the total load on the foot during static stance and reduced peak pressures during walking, suggesting it may improve healing outcomes for foot ulcers compared to traditional boots.

In contrast, the rigid and hinged boots provided minimal offloading and altered ankle mechanics, with the hinged boot leading to less efficient movement, indicating that boot design plays a crucial role in pressure relief and overall effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of existing and novel walker boot designs on offloading and gait mechanics. Bruening, DA., Huber, SC., Parry, DJ., et al.[2022]

Intelligent pressure offloading footwear is being developed to autonomously adapt to changing plantar pressures in people with diabetes, which is crucial for preventing diabetic foot ulcers and potential amputations.

This innovative footwear features an auto-contouring insole that continuously redistributes high pressure areas while resembling conventional shoes, aiming to improve patient adherence and usability.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intelligent plantar pressure offloading for the prevention of diabetic foot ulcers and amputations. Hemler, SL., Ntella, SL., Jeanmonod, K., et al.[2023]

Citations

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pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC9846414/

Smart Offloading Boot System for Remote Patient Monitoring

This is the first smart offloading system that enables remote patient monitoring and real-time adherence and activity reporting.

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phrmafoundation.org

phrmafoundation.org/news-events/blog/a-smart-boot-and-digital-monitoring-platform-to-improve-wound-healing-for-diabetic-foot-ulcer/

A Smart Boot and Digital Monitoring Platform to Improve ...

His PhF-supported research focuses on helping patients better manage diabetic foot ulcers (DFUs) using digital health technologies. For patients ...

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Smart Boot Use to Measure Offloading Adherence

The purpose of this study is to help people with diabetes who develop neuropathic diabetic foot ulcers (DFUs). These ulcers, or sores, if left untreated can ...

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pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/35048739/

Smart Offloading Boot System for Remote Patient Monitoring

Future studies warrant clinical validation of real-time non-adherence alerting to improve wound healing outcomes in people with diabetic foot ...

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digitalcommons.library.tmc.edu

digitalcommons.library.tmc.edu/cgi/viewcontent.cgi?article=1063&context=aging_research

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This study evaluates the SmartBoot edge-computing system—a wearable, real-time remote monitoring solution integrating an inertial measurement ...

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clinicaltrials.gov

clinicaltrials.gov/study/NCT04460573

Smart Boot Use to Measure Offloading Adherence

The purpose of this study is to help people with diabetes who develop neuropathic diabetic foot ulcers (DFUs). These ulcers, or sores, if left untreated can ...