Remote Temperature Monitoring for Diabetic Foot Care

(STOP Trial)

Recruiting at 2 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

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.

What data supports the effectiveness of the treatment Remote Temperature Monitoring for Diabetic Foot Care?

Research shows that using remote foot temperature monitoring can help predict and prevent diabetic foot ulcers, which are serious wounds that can lead to complications like amputation. Studies have found that regularly checking foot temperature can reduce the risk of these ulcers in people with diabetes. ^{1 2 3 4 5}

Is remote temperature monitoring for diabetic foot care safe for humans?

Research on remote temperature monitoring devices, like the Podimetrics SmartMat, shows they are generally safe for use in humans. These devices are designed to help detect foot problems early in people with diabetes, and studies have shown they are easy to use and reliable. ^{1 3 5 6 7}

How is the Remote Temperature Monitoring System unique for diabetic foot care?

The Remote Temperature Monitoring System, like the Podimetrics SmartMat, is unique because it allows for daily monitoring of foot temperature remotely, which can help predict and prevent diabetic foot ulcers by detecting early signs of complications. Unlike traditional methods that require comparing temperatures between both feet, this system can monitor a single foot, making it suitable for patients with wounds or amputations. ^{1 3 5 8 9}

What is the purpose of this trial?

Diabetic foot ulcers are common, debilitating, and costly complications of diabetes, disproportionately impacting Black and rural Veterans. Forty percent of individuals have an ulcer recurrence within a year of ulcer healing and 65% within 5 years. Monitoring plantar foot temperatures is one of the few interventions that reduces the risk of ulcer recurrence. Despite the evidence, adoption has been poor because the original procedures, including the use of handheld thermometers, were burdensome and time-consuming. Podimetrics, a private company, has developed a temperature monitoring system involving a "smart" mat that can wirelessly transmit data and a remote monitoring team that works with VA providers to assist with triage and monitoring. This care model has incredible promise, but has been untested in VA. The investigators propose to conduct a randomized trial to evaluate effectiveness of remote temperature monitoring as well as costs. Additionally, the investigators will evaluate the implementation process, including barriers and facilitators to use among key stakeholders.

Research Team

Alyson J. Littman, PhD MPH

Principal Investigator

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

Eligibility Criteria

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

Prisoner

You have dementia.

I regularly monitor my temperature at home.

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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]

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]

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]

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 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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

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

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

Skin temperature monitoring reduces the risk for diabetic foot ulceration in high-risk patients. [2022]

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

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

4. 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]

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

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

6. Switzerland 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. [2021]

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

Continuous Temperature-Monitoring Socks for Home Use in Patients With Diabetes: Observational Study. [2020]

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

Detection of diabetic foot hyperthermia by using a regionalization method, based on the plantar angiosomes, on infrared images. [2020]

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

Use of a Remote Temperature Monitoring Mat for the Early Identification of Foot Ulcers. [2021]