If you could prevent a diabetic foot wound and create revenue at the same time, why wouldn’t you start today?

Arche LEAP Vitals⁺® Utilization and Outcomes Demonstration Study on Skin Integrity

Please don’t let the word study frighten you away. Before you click off this page, please consider the clinical and financial benefits that you can gain by participating in the Arche LEAP Vitals⁺  protocol

First, there is no additional paperwork for you. We are looking behind the scenes at non-identifiable aggregated utilization data to measure, monitor and manage LEAP outcomes. The only risk is not participating.

Watch the video below to learn more and click the button to apply.

Thank you for your interest in joining the largest LEAP demonstration study in history. If selected, your practice will be a center of excellence in the proactive prevention of diabetic foot complications.

Incorporating these 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.

Why join LEAP Vitals⁺ Demonstration Study?

  • Enhance understanding of skin-related risk factors in diabetes-related wounds and amputations.

  • Proactively prevent and reduce diabetes-related wounds and amputations.

  • Increase patient engagement.

  • Improve patient and practice outcomes.

Together, we can collaborate to transform skin health clinical protocols, reduce diabetes-related foot wounds and amputations and build thriving podiatric practices.

Your Commitment

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) 

Abstract/Study Parameters

Background:  Comprehensive assessment of skin health is essential for proactive prevention of diabetic foot ulcers.  In the past, dry skin was assessed using visual assessment only but 'how dry' is critical in applying appropriate treatment protocol and improving outcomes.  All too frequently clinical assessment does not capture the underlying inflammation that is the precursor leading to skin ulceration. Accordingly, Arche Healthcare has developed a suite of innovative tools aimed at early detection of impending skin breakdown.  This suite includes DermaStat (SMI - Skin Moisture Index), IRStat (temperature/vascular assessment), and Neuropad (sudomotor dysfunction) all indicators of skin integrity, which we have assembled into a kit labeled LEAP Vitals⁺. 

Purpose:  To assess the ease of early Adaptation, Adoption, and Integration into current podiatric workflow as well as to evaluate the quick, proactive implementation of LEAP Vitals⁺ leading to data-driven decision making and improved preventative outcomes. 

Methods: Using the provided LEAP Vitals tools (DermaStat and IRStat), all participating Podiatric physicians shall at the start of each at-risk footcare visit assess the medical necessity for the described E&M. (Dry/very dry SMI or hot spot or vascular referral). Our scientific panel will collect and review survey responses via email as well as 1:1 interviews for Phase 1 performance analysis and Phase 2 will follow thereafter for those DPMs who have successfully incorporated LEAP Vitals into their practices during Phase 1. Specifically, Phase 2 will further assess the continuing adoption of LEAP Vitals⁺ and the addition of PressureStat for the assessment of motor changes allowing the integration of a true Comprehensive Diabetic Foot Examination (CDFE) assessing all elements of DPN.