OneStep Foot Scanner for Foot Ulcer

Recruiting at 1 trial location

Overseen By Maria Ryan

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Bluedrop Medical Limited

Disqualifiers: Charcot arthropathy, Foot infection, Ischemia, others

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

Compensation: Varies

Number of Visits: Unknown

100 Participants Needed

Trial Summary

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It seems likely that you can continue your medications, but you should confirm with the study team.

What data supports the effectiveness of the treatment Remote ThermoVisual Monitoring (RTVM) for foot ulcers?

Research shows that remote foot-temperature monitoring systems can accurately predict diabetic foot ulcers, and infrared thermography has been useful in preventing ulcer recurrence in high-risk diabetic patients. These findings suggest that RTVM, which involves remote monitoring, could be effective in managing foot ulcers. ^{1 2 3 4 5}

Is the OneStep Foot Scanner safe for humans?

The OneStep Foot Scanner, also known as Remote ThermoVisual Monitoring (RTVM), has been used in studies for monitoring foot temperature to prevent diabetic foot ulcers. These studies suggest that the technology is feasible and safe for use in humans, as it helps in early detection of foot disorders without reported safety concerns. ^{1 6 7 8 9}

How is the OneStep Foot Scanner for Foot Ulcer treatment different from other treatments?

The OneStep Foot Scanner treatment uses Remote ThermoVisual Monitoring (RTVM) to detect early signs of foot ulcers by monitoring temperature changes, which is unique compared to traditional methods that rely on physical examination. This approach allows for early intervention and remote monitoring, potentially reducing the incidence of severe ulcers and improving patient outcomes. ^{1 2 3 10 11}

What is the purpose of this trial?

This study is a prospective, observational investigation evaluating the effectiveness of Remote ThermoVisual Monitoring (RTVM) in the early detection of diabetic foot ulcers (DFUs) in high-risk populations. The primary objective is to compare the incidence of Wagner stage 2 or higher DFUs at the time of presentation between patients using RTVM and a matched control group from a retrospective patient database. Participants will include adults aged 18 years or older with type 1 or type 2 diabetes mellitus and a history of a plantar DFU that healed within the past five years. The study will enroll approximately 100 participants across up to 30 centers affiliated with SerenaGroup®. The intervention involves daily use of the OneStep Foot Scanner™, which measures temperature and captures visual images of the soles of the feet to detect signs of inflammation or anomalies. Secondary objectives include evaluating ulcer-free survival, amputation-free survival, time to first evaluation for new DFUs, and healthcare utilization rates. Exploratory endpoints will assess neuropathy-specific quality of life and the costs associated with ulcer and amputation care. Participants will be monitored over a period of 12 months. Results from this study aim to provide insights into the efficacy of RTVM as a preventative tool for managing diabetic foot health and reducing the burden of DFUs in high-risk populations.

Research Team

Thomas Serena

Principal Investigator

Serena Group

Eligibility Criteria

Adults over 18 with type 1 or type 2 diabetes and a history of foot ulcers in the past five years can join this study. They must have healed from their last ulcer, own a phone for updates, and be able to handle foot scanning pressure if they currently have a minor ulcer.

Inclusion Criteria

I had a foot ulcer in the past 5 years.

I have a phone to receive study updates.

My foot ulcer is healing well enough for a scan, according to my doctor.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Monitoring

Participants use the OneStep Foot Scanner™ daily to capture thermographic and visual data of the soles of their feet

12 months

Daily remote monitoring

Follow-up

Participants are monitored for safety and effectiveness after the monitoring period

4 weeks

Treatment Details

Interventions

• Remote ThermoVisual Monitoring (RTVM)

Trial Overview The trial is testing the OneStep Foot Scanner™ to see if it helps spot signs of serious foot ulcers early on by checking temperature changes and taking pictures of feet daily. It's compared against past data to check its effectiveness.

Participant Groups

Group I: Use of device Active Control 1 Intervention

This cohort will be recruited to use the OneStep Foot Scanner in their homes everyday for 12 months

Group II: Control Group from Retrospective Patient Database Active Control 1 Intervention

Patients with a history of previous DFU(s) will be matched with participants in the active arm and analyzed

Who Is Running the Clinical Trial?

Bluedrop Medical Limited

Lead Sponsor

Trials

3

Recruited

160+

Serena Group

Collaborator

Trials

6

Recruited

790+

Serena Group

Collaborator

Trials

6

Recruited

790+

Findings from Research

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]

A novel optical imaging system using a 3D camera and disposable markers demonstrated good reliability for remote assessment of diabetic foot wounds, with low measurement variability (3.3% intraoperator and 11.9% interoperator).

Clinicians were able to accurately measure and assess wounds remotely using only 3D images, although subjective assessments, like the need for debridement, showed lower agreement compared to in-person evaluations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Remote assessment of diabetic foot ulcers using a novel wound imaging system. Bowling, FL., King, L., Paterson, JA., et al.[2015]

The FLIR ONE smartphone-connected device demonstrated perfect reliability and validity in assessing inflammation, with kappa coefficients of 1.00 for both criterion-related validity and inter-rater/intra-rater reliability, based on a study of 16 thermal images from 8 patients.

This pilot study suggests that FLIR ONE can serve as a reliable alternative to traditional thermography for evaluating subclinical inflammation in pressure ulcers and diabetic foot conditions, potentially enhancing bedside clinical assessments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of smartphone attached mobile thermography assessing subclinical inflammation: a pilot study. Kanazawa, T., Nakagami, G., Goto, T., et al.[2022]

The study assessed 50 diabetic foot ulcers using mobile phone images and found that the diagnostic accuracy for remote assessment was low, with positive likelihood ratios ranging from 1.3 to 4.2 and negative likelihood ratios from 0.13 to 0.88.

Inter-observer reliability for the assessments varied significantly, indicating that mobile phone images should not be relied upon as a standalone diagnostic tool; clinicians should seek additional information to support treatment decisions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The validity and reliability of remote diabetic foot ulcer assessment using mobile phone images. van Netten, JJ., Clark, D., Lazzarini, PA., et al.[2019]

In a study involving 110 participants with diabetes and a history of foot ulcers, monthly thermography combined with standard foot care did not significantly reduce the recurrence of foot ulcers compared to standard care alone, with 62% of the intervention group remaining ulcer-free versus 56% in the control group.

The trial's results suggest that while thermal imaging did not show a significant benefit in preventing ulcer recurrence, it has provided valuable insights for designing future studies with longer follow-up periods and better stratification of participants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Infrared thermography and ulcer prevention in the high-risk diabetic foot: data from a single-blind multicentre controlled clinical trial. Petrova, NL., Donaldson, NK., Tang, W., et al.[2021]

Regular monitoring of foot temperature in diabetic patients can significantly reduce the risk of serious complications like foot ulcers and amputations, improving overall quality of life.

Infrared thermometry and liquid crystal thermography are the most effective technologies currently available for monitoring foot temperature, and they can enhance existing foot examination practices in diabetes care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An overview of temperature monitoring devices for early detection of diabetic foot disorders. Roback, K.[2010]

In a study of 160 patients using smart socks for remote temperature monitoring, the average utilization was high, with patients wearing the socks for 22 to 25 days per month and a retention rate of 91.9% over 7 months.

The high compliance and utilization rates suggest that smart socks could be an effective tool for monitoring temperature and potentially preventing foot ulcers, warranting further research into their clinical outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Utilization of a Smart Sock for the Remote Monitoring of Patients With Peripheral Neuropathy: Cross-sectional Study of a Real-world Registry. Scholten, HJ., Shih, CD., Ma, R., et al.[2022]

In a study of 924 patients using remote foot temperature monitoring (RTM) compared to 2,757 nonenrolled patients, RTM did not significantly reduce the incidence of lower-extremity amputation (LEA) or all-cause hospitalization.

However, RTM was associated with a significantly reduced risk of death, suggesting potential benefits in mortality for patients with a history of diabetic foot ulcers, despite not impacting LEA or hospitalization rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of the Effectiveness of Remote Foot Temperature Monitoring for Prevention of Amputation in a Large Integrated Health Care System. Littman, AJ., Timmons, AK., Korpak, A., et al.[2023]

A novel approach to monitor the temperature of a single foot in patients at risk for diabetic foot complications showed a high predictive accuracy, identifying 91% of impending non-acute plantar foot ulcers an average of 41 days before they occurred.

This method allows for effective monitoring in high-risk patients, such as those with a wound or lower extremity amputation, potentially improving outcomes and reducing healthcare costs by enabling early intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Unilateral remote temperature monitoring to predict future ulceration for the diabetic foot in remission. Lavery, LA., Petersen, BJ., Linders, DR., et al.[2020]

A new thermal imaging device is being developed to help reduce the incidence of diabetic foot ulcers (DFU), with initial trials planned at three clinical centers involving over 100 high-risk patients.

The first trial will establish a baseline with healthy volunteers, while the second will compare standard care for high-risk feet with standard care plus thermal imaging to assess its effectiveness in preventing DFUs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A medical thermal imaging device for the prevention of diabetic foot ulceration. Machin, G., Whittam, A., Ainarkar, S., et al.[2022]

Diabetes affects 10% of U.S. adults, with up to a third developing diabetic foot ulcers (DFUs), which can lead to severe complications like amputation and high mortality rates, particularly in communities of color.

The use of computer vision and machine learning techniques for remote monitoring and automated classification of DFUs could significantly improve wound care by enabling self-monitoring, assisting clinicians in triaging, and facilitating timely interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intelligent Care Management for Diabetic Foot Ulcers: A Scoping Review of Computer Vision and Machine Learning Techniques and Applications. Baseman, C., Fayfman, M., Schechter, MC., et al.[2023]

References

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

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

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

Remote assessment of diabetic foot ulcers using a novel wound imaging system. [2015]

3. England pubmed.ncbi.nlm.nih.gov

Use of smartphone attached mobile thermography assessing subclinical inflammation: a pilot study. [2022]

4. England pubmed.ncbi.nlm.nih.gov

The validity and reliability of remote diabetic foot ulcer assessment using mobile phone images. [2019]

5. England pubmed.ncbi.nlm.nih.gov

Infrared thermography and ulcer prevention in the high-risk diabetic foot: data from a single-blind multicentre controlled clinical trial. [2021]

6. England pubmed.ncbi.nlm.nih.gov

An overview of temperature monitoring devices for early detection of diabetic foot disorders. [2010]

7. Canada pubmed.ncbi.nlm.nih.gov

Utilization of a Smart Sock for the Remote Monitoring of Patients With Peripheral Neuropathy: Cross-sectional Study of a Real-world Registry. [2022]

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

Evaluation of the Effectiveness of Remote Foot Temperature Monitoring for Prevention of Amputation in a Large Integrated Health Care System. [2023]

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

Unilateral remote temperature monitoring to predict future ulceration for the diabetic foot in remission. [2020]

10. England pubmed.ncbi.nlm.nih.gov

A medical thermal imaging device for the prevention of diabetic foot ulceration. [2022]

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

Intelligent Care Management for Diabetic Foot Ulcers: A Scoping Review of Computer Vision and Machine Learning Techniques and Applications. [2023]