OneStep Foot Scanner for Foot Ulcer

Not currently 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method for early detection of diabetic foot ulcers using the OneStep Foot Scanner. The aim is to determine if this scanner can identify foot problems before they worsen, especially compared to past cases without the device. It is ideal for individuals with type 1 or type 2 diabetes who have had a foot ulcer in the past five years and have access to a phone for study updates. Participants will use the scanner daily at home for a year, with the trial aiming to improve foot health and reduce the need for serious treatments like amputations. The study involves Remote ThermoVisual Monitoring (RTVM), a method for remotely monitoring foot temperature and visual changes. As an unphased trial, it offers participants the opportunity to contribute to innovative research that could enhance early detection and prevention of diabetic foot complications.

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 prior data suggests that the OneStep Foot Scanner is safe for detecting foot ulcers?

Research has shown that remote foot-temperature monitoring systems can accurately predict diabetic foot ulcers. Early results indicate that the OneStep Foot Scanner, part of the Remote ThermoVisual Monitoring (RTVM) method, is easy to use. This tool measures foot temperatures and takes pictures to detect early signs of problems.

Studies have demonstrated that similar remote monitoring systems are safe for people with diabetes, with no major safety concerns reported. These devices are designed for simple daily use at home, and participants generally find them easy to manage.

Overall, RTVM appears to be a promising and safe way to prevent serious foot issues in people with diabetes. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Remote ThermoVisual Monitoring (RTVM) for foot ulcers because it introduces a novel approach to early detection and prevention. Unlike traditional treatments that often focus on managing existing ulcers through topical medications or wound dressings, RTVM uses a thermal imaging device that patients can use at home. This technology allows for daily monitoring of foot temperature changes, which can signal potential ulcers before they fully develop. By catching these issues early, RTVM has the potential to reduce the occurrence of severe ulcers and improve patient outcomes.

What evidence suggests that Remote ThermoVisual Monitoring is effective for early detection of diabetic foot ulcers?

Studies have shown that Remote ThermoVisual Monitoring (RTVM) can help detect early signs of diabetic foot ulcers. In about 82% of cases, podiatrists found that the scans identified skin problems before they became serious. This early detection allows patients to receive treatment sooner, potentially preventing ulcers from worsening. In this trial, participants in the active arm will use the OneStep Foot Scanner to monitor foot temperature and images daily. Research suggests this practice could lower the risk of new ulcers forming. Overall, RTVM shows promise as a way to manage foot health in people with diabetes. ^{1 2 3 6 7}

Who Is on the Research Team?

Thomas Serena

Principal Investigator

Serena Group

Are You a Good Fit for This Trial?

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 have a phone to receive study updates.

I had a foot ulcer in the past 5 years.

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

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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 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]

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 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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12533988/

Assessing the Possibility of Recurrent Diabetic Foot Ulcer ... We have demonstrated the feasibility of a novel, remote visual and thermal foot scanning and monitoring system for potential use in the ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06053047

Remote Monitoring of the Diabetic Foot to Prevent Re ... The purpose of this study is to understand the effects of the Bluedrop Monitoring System (BMS) on the development of diabetic foot ulcers.

3. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06782386/remote-temperature-and-visual-monitoring-to-help-manage-diabetic-foot-ulcers

Remote Temperature and Visual Monitoring to Help Manage ... This study is a prospective, observational investigation evaluating the effectiveness of Remote ThermoVisual Monitoring (RTVM) in the early detection of ...

4. withpower.com withpower.com/trial/phase-diabetic-foot-1-2025-6574c

OneStep Foot Scanner for Foot Ulcer This study is a prospective, observational investigation evaluating the effectiveness of Remote ThermoVisual Monitoring (RTVM) in the early detection of ...

5. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/abs/10.1002/dmrr.70096

Assessing the Possibility of Recurrent Diabetic Foot Ulcer ... Podiatrists agreed that scans enabled the identification of skin integrity issues earlier than standard care (in 82% cases), finding visual scan ...

6. bluedropmedical.com bluedropmedical.com/wp-content/uploads/2024/12/Evaluating-the-Impact-of-a-Remote-Monitoring-Service-on-Limb-Salvage-Outcomes-in-Diabetic-Foot-Management-and-Care.pdf

Evaluating-the-Impact-of-a-Remote-Monitoring-Service-on- ... Diabetic Foot Ulcers (DFUs) are associated with high morbidity and mortality. After experiencing a DFU, approximately 40% of individuals develop a subsequent ...

7. ctv.veeva.com ctv.veeva.com/study/remote-temperature-and-visual-monitoring-to-help-manage-diabetic-foot-ulcers

Remote Temperature and Visual Monitoring To Help Manage ... This study aims to provide critical insights into the feasibility of implementing RTVM as a preventive tool in routine diabetic foot care and ...