Smart Boot for Diabetic Foot Ulcers

Recruiting at 3 trial locations

Overseen By Fabiola Rodriguez

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

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. 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 data supports the effectiveness of the Smart Boot treatment for diabetic foot ulcers?

Research shows that smart offloading boots, which include remote monitoring and pressure redistribution features, can improve patient adherence and reduce high pressure areas on the foot, which are critical for healing diabetic foot ulcers. Additionally, digital health technologies like wearables and telehealth have been shown to empower patients in self-care and improve remote management of diabetic foot conditions. ^{1 2 3 4 5}

Is the Smart Boot for Diabetic Foot Ulcers safe for humans?

The Smart Boot and similar devices have been tested for diabetic foot ulcers, focusing on patient adherence and user experience. Preliminary assessments show encouraging results for safety and usability, but some users reported issues with comfort and device malfunctions, indicating a need for further refinements. ^{1 2 5 6 7}

How is the Smart Boot treatment different from other treatments for diabetic foot ulcers?

The Smart Boot is unique because it combines a boot with a smartwatch app and cloud dashboard to monitor patient adherence and activity remotely, helping ensure proper use and physical activity. Unlike traditional offloading devices, it uses intelligent technology to adapt to pressure changes on the foot, improving comfort and effectiveness in preventing and treating diabetic foot ulcers. ^{1 2 3 8 9}

What is the purpose of this trial?

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 increase the chance of amputation. Part of the treatment is to have the person wear a diabetic shoe or boot to help their foot heal. Sometimes people don't wear the boot like they are told. The investigators want to compare three different kinds of diabetic boots to see if they can help make it easier for people to wear their boots as instructed. The investigators will look at three groups of participants: the first group will wear a boot that can't be taken off. The second group will wear a boot that can be taken off, and they will get counseling about how important it is to follow instructions as to how often and when to wear the boot. The third group will wear a "smart" boot, which will interact with the person through a smart watch and smart phone, and give them direct feedback about how they are doing with following their boot wearing prescription. The investigators will also be looking at how much physical activity, like walking, the participants do. And they will compare how well participants sleep and rate their quality of life in the three different boots. The investigators think that giving participants information about how much they are wearing their boot using readily available technology will help them to follow the doctor's directions better, and help their wounds heal faster.

Research Team

David G Armstrong, DPN, MD, PhD

Principal Investigator

Professor of Surgery, Keck School of Medicine of USC

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

Group I: Smart boot removable+reinforcement Experimental Treatment 1 Intervention

Smart boot with, removable, with reinforcement of adherence via smart watch and smart phone as well as remote patient monitoring.

Group II: Smart boot removable Active Control 1 Intervention

Smart boot, removable, without feedback on adherence.

Group III: Smart boot irremovable Active Control 1 Intervention

Smart boot rendered irremovable with cohesive bandage; no feedback on adherence.

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+

Baylor College of Medicine

Collaborator

Trials

1,044

Recruited

6,031,000+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

References

1. United States 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. [2023]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Intelligent plantar pressure offloading for the prevention of diabetic foot ulcers and amputations. [2023]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Harnessing Digital Health Technologies to Remotely Manage Diabetic Foot Syndrome: A Narrative Review. [2022]

4. Switzerland pubmed.ncbi.nlm.nih.gov

The Potential Role of Sensors, Wearables and Telehealth in the Remote Management of Diabetes-Related Foot Disease. [2023]

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

Feasibility and Efficacy of a Smart Mat Technology to Predict Development of Diabetic Plantar Ulcers. [2022]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Patient and Provider Perspective of Smart Wearable Technology in Diabetic Foot Ulcer Prevention: A Systematic Review. [2021]

7. England pubmed.ncbi.nlm.nih.gov

The effect of existing and novel walker boot designs on offloading and gait mechanics. [2022]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Taking a Load Off: User Perceptions of Smart Offloading Walkers for Diabetic Foot Ulcers Using the Technology Acceptance Model. [2023]

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

Innovative intelligent insole system reduces diabetic foot ulcer recurrence at plantar sites: a prospective, randomised, proof-of-concept study. [2021]