Remote Temperature Monitoring for Diabetic Foot Care

(STOP Trial)

Recruiting at 4 trial locations

Overseen By Rachel M Thomas

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Disqualifiers: Dementia, Unable to ambulate, others

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

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

Compensation: Varies

Number of Visits: Unknown

Duration: 24 months

800 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a new "smart" mat that monitors foot temperature can help prevent the recurrence of diabetic foot ulcers. The mat collects data and sends it wirelessly to a team collaborating with VA providers to manage care. Participants will receive either this new remote foot temperature monitoring system (the Podimetrics SmartMat) along with enhanced usual care or just the enhanced usual care. Veterans with diabetes who have had foot ulcers or lower limb amputations and can read English might be suitable for this trial. As an unphased trial, this study offers veterans the chance to contribute to innovative research that could improve diabetic foot care.

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 prior data suggests that this remote temperature monitoring system is safe for diabetic foot care?

Research has shown that monitoring foot temperature remotely is a safe method to help prevent diabetic foot ulcers. This system uses a "smart" mat to detect changes in foot temperature, aiming to identify issues like inflammation early and prevent serious foot problems.

Studies have found that patients tolerate this system well, with no reports of harmful side effects from using the temperature monitoring mat. Instead, it offers a simple and non-invasive way to monitor foot health.

The Veterans Affairs (VA) has used this technology to help reduce hospital visits and prevent amputations. The smart mat requires no invasive procedures, making it a safe option for those at risk of foot ulcers. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about remote foot temperature monitoring for diabetic foot care because it offers a proactive approach to preventing serious complications like ulcers and amputations. Unlike traditional treatments that focus on wound care after problems arise, this method continuously tracks foot temperature to catch issues early. This real-time monitoring could lead to quicker interventions, reducing the risk of severe outcomes for patients with diabetes.

What evidence suggests that the remote temperature monitoring system is effective for diabetic foot care?

Research has shown that monitoring foot temperatures can help prevent diabetic foot ulcers. In this trial, participants in the "Remote temperature monitoring + enhanced usual care" arm will use the SmartMat, a device that checks foot temperature from home. One study found that using the SmartMat was linked to a 37% decrease in deaths over one year for people who had diabetic foot ulcers before. Another small study suggested that checking foot temperature remotely might reduce the risk of foot ulcers and amputations. However, solid proof is still lacking that this system lowers the risk of leg amputations or hospital visits for any reason. Overall, the SmartMat appears promising for improving health outcomes for those with diabetic foot problems. ^{6 7 8 9 10}

Who Is on the Research Team?

Alyson J. Littman, PhD MPH

Principal Investigator

VA Puget Sound Health Care System Seattle Division, Seattle, WA

Are You a Good Fit for This Trial?

This trial is for Veterans with diabetes who can read English and have had either a lower extremity amputation or foot ulcer in the past 24 months. It's not for those with dementia, prisoners, current users of in-home temperature monitoring, non-ambulatory individuals, or those with severe peripheral arterial disease.

Inclusion Criteria

I am a veteran diagnosed with diabetes.

Able to understand/read English

I had a leg amputation up to 2 years ago, and it may not be fully healed.

Exclusion Criteria

You have dementia.

Prisoner

I regularly monitor my temperature at home.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are enrolled in remote foot temperature monitoring in addition to enhanced usual care

24 months

Regular remote monitoring and periodic in-person visits

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Enhanced usual care
• Remote foot temperature monitoring system

Trial Overview The study tests if a 'smart' mat that monitors foot temperature and sends data to a remote team helps prevent ulcers compared to usual care. The goal is to see if this tech makes it easier and more effective for patients to monitor their condition.

How Is the Trial Designed?

Group I: Remote temperature monitoring + enhanced usual care Experimental Treatment 2 Interventions

Enrollment in remote foot temperature monitoring in addition to enhanced usual care (described below)

Group II: Enhanced usual care Experimental Treatment 1 Intervention

Usual care is based on the VA's amputation prevention program (PAVE - Preventing Amputation in Veterans Everywhere - VHA Directive 1410), which provides a model of care for patients at risk for amputation as well as patients who have already undergone an amputation. Usual care will be enhanced by providing resources (e.g., information through written newsletters) relevant to a population of Veterans with diabetes, including information on nutrition and cooking, physical activities, and Whole Health opportunities

Remote foot temperature monitoring system is already approved in United States for the following indications:

Approved in United States as Podimetrics SmartMat for:

• Diabetic foot ulcer prevention
• Diabetic foot condition monitoring

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Published Research Related to This Trial

Remote temperature monitoring (RTM) effectively detected inflammation in diabetic foot ulcers (DFUs) in 4 veteran patients, leading to timely clinical interventions that prevented further complications.

All patients healed quickly after treatment, demonstrating that RTM can enhance diabetic foot care by facilitating early identification and management of pre-ulcerative lesions, potentially reducing overall morbidity and healthcare costs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of a Remote Temperature Monitoring Mat for the Early Identification of Foot Ulcers. Banks, JL., Petersen, BJ., Rothenberg, GM., et al.[2021]

A pilot study involving 35 patients with diabetic peripheral neuropathy demonstrated that wireless sensor-embedded socks accurately monitor foot temperatures, with measurements within 0.2°C of a reference standard, indicating their reliability for detecting temperature changes that could signal foot ulcers.

Patients found the sensor-embedded socks comfortable and easy to use, scoring them highly on a 10-point scale, suggesting that continuous temperature monitoring could be a practical and effective method for early detection of diabetic foot ulcers in a home setting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Continuous Temperature-Monitoring Socks for Home Use in Patients With Diabetes: Observational Study. Reyzelman, AM., Koelewyn, K., Murphy, M., et al.[2020]

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 study involving 60 diabetic patients found that a temperature difference of more than 2.2°C between corresponding areas of the left and right foot significantly increases the risk of developing ulcers, highlighting the importance of monitoring foot temperature.

The researchers developed a specialized software system that analyzes thermal images to calculate temperature differences in various regions of the foot, which can help in early detection and prevention of serious diabetic foot complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Detection of diabetic foot hyperthermia by using a regionalization method, based on the plantar angiosomes, on infrared images. Liu, Y., Polo, A., Zequera, M., et al.[2020]

In an 18-month study involving 225 high-risk diabetes patients, those using home temperature monitoring (Dermal Thermometry Group) had a significantly lower incidence of foot ulcers (4.7%) compared to those receiving standard therapy (12.2%).

The study found that monitoring temperature differences between feet could predict ulceration risk, as patients who developed ulcers had much higher temperature differences prior to ulceration, suggesting that self-monitoring can effectively reduce ulceration risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Skin temperature monitoring reduces the risk for diabetic foot ulceration in high-risk patients. Armstrong, DG., Holtz-Neiderer, K., Wendel, C., 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]

The new plantar foot temperature monitoring device demonstrated excellent agreement with a reference infrared thermometer in measuring foot temperatures in people with diabetes, particularly in areas prone to ulcers, indicating its potential for early ulcer detection.

The device showed high test-retest reliability and was well-received by users, scoring between 3.8 and 4.3 on a 5-point scale for usability, suggesting it could be a practical tool for at-home monitoring to prevent diabetic foot ulcers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Concurrent Validity, Test-Retest Reliability and Usability of a New Foot Temperature Monitoring System for Persons with Diabetes at High Risk of Foot Ulceration. Veneman, T., Schaper, NC., Bus, SA.[2021]

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]

Citations

1. diabetesjournals.org diabetesjournals.org/care/article/46/8/1464/151481/Evaluation-of-the-Effectiveness-of-Remote-Foot

Evaluation of the Effectiveness of Remote Foot Temperature ... This study does not provide support that RTM reduces the risk of LEA or all-cause hospitalization in individuals with a history of diabetic foot ulcer.

2. healthaffairs.org healthaffairs.org/sponsored-content/new-evidence-on-remote-foot-temperature-monitoring-what-does-a-recent-vha-study-really-tell-us-about-the-impact

New evidence on Remote Foot Temperature Monitoring ... The study's analyses showed that enrollment in the SmartMatTM Program was associated with a 37% reduction in 1-year mortality.

3. reporter.nih.gov reporter.nih.gov/search/14E9CE024F8FC5D27598B8961CAA4A01A2FFCEB861BF/project-details/11019677

Home foot-temperature monitoring through smart mat ... Significance: The only evidence that remote temperature monitoring (RTM) reduces the risk of ulceration and amputation comes from a small observational study (n ...

4. podimetrics.com podimetrics.com/providers/clinical-evidence/

Clinical Evidence Study: SmartMat for Predicting Diabetic Foot Ulcers ... “Implementation of a Remote Temperature Monitoring for the Prevention of Diabetic Foot Ulcers”.

5. centerwatch.com centerwatch.com/clinical-trials/listings/NCT05728411/effectiveness-of-remote-foot-temperature-monitoring

Effectiveness of Remote Foot Temperature Monitoring The investigators propose to conduct a randomized trial to evaluate effectiveness of remote temperature monitoring as well as costs.

6. podimetrics.com podimetrics.com/

Podimetrics - Complex Diabetes Virtual Care Solution Central to our solution is the SmartMat™, a scientifically validated technology that combines clinical intelligence, remote monitoring, and personalized support ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7170172/

Remote Temperature Monitoring of the Diabetic Foot The objective of daily foot temperature monitoring is to identify impending inflammatory foot conditions, such as DFUs, infection, and acute Charcot ...

8. podimetrics.com podimetrics.com/beyond-the-foot-how-remote-monitoring-is-evolving/

Beyond the Foot: How Remote Monitoring is Evolving By tracking subtle increases in foot temperature, clinicians could detect inflammation days or even weeks before a diabetic foot ulcer appeared.

9. drc.bmj.com drc.bmj.com/content/7/1/e000696

Unilateral remote temperature monitoring to predict future ... Daily remote foot temperature monitoring is an evidence-based preventive practice for patients at risk for diabetic foot complications.

10. marketplace.va.gov marketplace.va.gov/innovations/reducing-hospital-admissions-and-amputation-prevention-remote-temperature-monitoring

VA remote temperature monitoring for amputation prevention Remote temperature monitoring involves the use of the Podimetrics SmartMat that uses thermal imaging to measure the daily temperature of a Veteran's foot.