Introduction

Congratulations, by joining the largest LEAP demonstration study in history and adding the Arche LEAP Vitals⁺® protocol, your practice has taken measures to prevent up to 50% of diabetes related amputations.  

Arche, with its cutting edge approach to innovation, assists our partners in closing care gaps and enhancing clinical documentation to support billing the appropriate E&M codes. This not only significantly reduces the costs of care; it supports our goals of improved patient health within a sustainable value and quality framework in a variety of healthcare environments. 

The FDA approved tools in the Arche LEAP Vitals⁺ protocol, which can be performed in just a few minutes, uses DermaStat®, IRStat® and Neuropad® to measure, monitor, and manage autonomic nerve function (sudomotor dysfunction) in patients with diabetes. 

Incorporating these “vitals” into your current at-risk foot care visit workflow,  you and your staff can help prevent diabetes related foot complications and create the medical necessity to potentially justify a reimbursable E&M visit. 

Your participation in this proactive LEAP strategy, will enroll you as a member of the Arche LEAP Collaborative, a huddle of like-minded individuals with a common goal of saving skin and limbs. 

Duration

This demonstration study will run for 6 weeks.  During this time Arche Healthcare will provide you with a Leap Vitals⁺ kit containing Dermastat, IRStat and 25 Neuropads (at no cost to you). 

Your Commitment 

Successful adaptation, adoption and integration of Arche LEAP Vitals⁺ into your practice starts with acceptance into the project.

• You will conduct Arche Leap Vitals⁺ exams on 25 of your current patients with Diabetes during their scheduled at-risk footcare visit. *note that this does not require a new/separate appointment but should be conducted on each at-risk foot care visit.  

• You will begin exams as soon as possible after receiving your Arche Leap Vitals⁺ kit and instructional video.  

• You will complete 2 surveys - First at 4 weeks and second at 6 weeks.  

We recognize that this program is not for everyone. Our recommendations of an annual assessment of sudomotor dysfunction follows 2024 ADA Standards of Care. It is our expectation that this recommendation will be followed and that your total number of patients with diabetes will have this standard applied. Based on your community of patients with Diabetes, you should have completed the 25 included exams by the end of the 6 weeks.    

If you are unable to fulfill the above commitment, Arche will provide you an RA and require return of the Leap VItals⁺ kit (tools and unused Neuropads) 

Following this - Phase 1 - of the demonstration study, you will be presented with the opportunity to join Phase 2, and expand your protocol to include PressureStat, a clinically proven and cost effective practical tool to quantify plantar pressure.