TempStat®

Risk Factor: Inflammation on the plantar foot surface

TempStat® is a multiple use, at-home temperature monitoring device used for daily self-examination of the foot for signs of inflammation (infection) and other damage. TempStat is the only medical device that is FDA cleared to detect early signs of inflammation on the plantar aspect of the foot.

Over the past four decades, several authors have suggested that skin temperature monitoring may be a valuable tool to detect sites at risk for ulceration in patients with diabetic peripheral neuropathy (DPN)1,2

According to a systematic review of randomized clinical trials to prevent the occurrence of plantar foot ulcers in patients with diabetes, once a patient has lost SWM sensation, self-measurement of plantar foot temperature, followed by off-loading when temperature differences are detected, is currently the onlyscientifically supported tool for the prediction and prevention of diabetic foot ulcers in an insensate foot3.

Temperature Monitoring to Assess, Predict, and Prevent Diabetic Foot Complications Lawrence A. Lavery, DPM, MPH, and David G. Armstrong, PhD, MD, DPM; 

Beyond the Monofilament for the Insensate Diabetic Foot A systematic review of randomized trials to prevent the occurrence of plantar foot ulcers in patients with diabetes Yadon Arad, MD1 , Vivian Fonseca, MD2, Anne Peters, MD3 AAron Vinik, MD4 

Diabetic Foot Self Examination with the Tempstat™ as an Integral Component of a Comprehensive Prevention Program RG. Frykberg, DPM, MPH 1, ATallis, DPM 2, ETierney, DPM 3 The Journal of Diabetic Foot Complications, Volume 1, Issue 1, No. 3

Learn more about TempStat (PDF)

TempStat Instructions – English (PDF)

TempStat Instructions – Spanish (PDF)

Arche OPTYX

Do you have a system that helps you automate documentation, improve patient outcomes and increase reimbursements simultaneously? The Arche LEAP Collaborative has developed the Arche OPTYX system which supports processes and protocols that will enable you transform into an insights-driven organization that has successfully turned evidence-based medicine into evidence-based practice while seamlessly meeting Medicare documentation requirements.

Our analytics capability leverages disparate data sources that enables you to monitor your progress toward targets and offers you information on your performance compared to the rest of the Arche LEAP Collaborative. As a result, you will be able to transform your practice into an insights-driven organization.

Arche LEAP Collaborative (ALC) Practice Registration

Let’s begin. The first step is to register and enroll in the Arche LEAP Collaborative. You can do this through the Take the LEAP link at archehealthcare.com. You will need an access code. If you don’t have one, you can let us know about your interest through the "Let’s Talk" link at archehealthcare.com or by speaking to the person who told you about the Arche LEAP Collaborative.

Populate and Update Practice Dashboard and Diabetes Patient Registry

When you join the Arche LEAP Alliance, we will gather information from your EHR system through an automated process to create a registry of patients with diabetes. Arche OPTYX will identify patients who should have an Arche CDFE (Comprehensive Diabetic Foot Exam), patients who have or have had wounds and amputations and it will also help you manage therapeutic footwear and insole prescriptions.

Training for Arche LEAP Captain

Training is essential to success and having a designated Arche LEAP Captain is an essential element of a successful program. The Arche LEAP Captain is the owner of the Arche LEAP Collaborative program in your practice. Arche LEAP Captains go through extensive training where they learn about the impact of diabetes on the lower extremities, techniques to educate patients on how to care for their feet and the protocols and processes of the Arche LEAP Collaborative program. To ensure LEAP Captains have effectively completed the necessary training, an evaluation of their proficiency as a Therapeutic Footwear Specialist is required at the conclusion of the training program.

Schedule CDFE Appointment

Once identified, patients who need an Arche CDFE should be scheduled for an appointment. All patients with diabetes should have at least one Arche CDFE per year. Additional Arche CDFEs will depend on the patient’s personal risk profile for developing diabetic foot complications and information about any new problems identified during an at-risk or routine appointment.

Arche CDFE

We think of the Arche CDFE as more than just a clinical exam. For us, the CDFE should be a Comprehensive Diabetic Foot Experience! Using our tools and processes turns a clinical examination into an experience that improves your patient’s health literacy by illustrating their personal risk and in response, teaching them best practices for self-care. This proactive approach leads to the prevention of ulcers and amputations.

Rx Documentation Procurement and Review

We make documentation easy! From the patient’s signature on a Release of Information authorization to the final Dispensing Package, the entire CDFE exam and process is managed through the Arche OPTYX program.

As documents are gathered, an ongoing review is conducted to ensure that all CMS requirements for completeness are met. We follow-up with the MD/DO managing the patient’s diabetes up to eight (8) times in an effort to assemble a complete documentation packet that will pass an audit. When all of the documentation is gathered and found to be satisfactory, the prescription is sent to be filled.

If there is an audit, all of the required documentation will be available in one place so that you can easily print or upload it to the requestor.

Rx Dispensed

All of the required documents for the fitting and dispensing appointment reside in Arche OPTYX.

During the appointment, the Arche LEAP Captain uses their Therapeutic Footwear Specialist Training to ensure proper footwear and insole fit and introduces home monitoring to the patient.

When the appointment is completed, all of the documentation is reviewed by the Documentation Team for thoroughness and accuracy. When correct and complete, the Dispensing Packet will be added to the rest of the documentation, and the prescription procurement packet will be complete.

Home Temperature and Moisture Monitoring

Arche Healthcare offers you the opportunity to provide your patients with an FDA approved at-home plantar temperature monitoring device that enables them to engage in their own self-care.

Patient Follow-up calls and texts

You are the front line for the care of the lower extremities of your patients with diabetes, and we want to ensure that they come back when they need to!

OPTYX will remind the ALC to call patients two weeks after they have had their therapeutic footwear and insole prescription dispensed. It will also text those that choose to participate in the ReCare program to remind them to come in for their annual CDFE, and for those that are eligible, to come in for their at-risk foot care appointments. Your ALC will also be provided with a list of patients to call who have not had a CDFE in the past year or longer so that your team can call and schedule them for their appointment.

Manage your outcomes

OPTYX equips healthcare providers and relevant healthcare stakeholders with the necessary tools to systematically identify and stratify patients with diabetes to reduce their risk for developing life-threatening diabetic foot complications. It is a patient and prescription management system that tracks and calculates adherence to protocols by each physician, each practice and the entire ALC.

When your registry of patient with diabetes is created, their prior history of wounds, amputations and footwear prescriptions is gathered. Outcomes are measured by comparing a two-year pre-program baseline with the incidence of wounds and amputations going forward. We will also track CDFE’s, at-risk foot care and footwear and insole prescriptions.