Welcome to Phase 2 of the LEAP Vitals⁺® Utilization and Outcomes Demonstration Study on Skin Integrity!

Thank you for your invaluable contribution to Phase 1! With your help, we’ve made significant progress in understanding diabetic foot care. We’re excited to invite you to continue making an impact by participating in Phase 2 of the study.

What’s Continuing in Phase 2?

In this phase, you’ll continue using DermaStat® and IRStat® during every at-risk foot care visit for patients with diabetes. These tools have been instrumental in providing crucial data and helping you adapt your care plans to optimize patient outcomes. By continuing these assessments, you’ll remain at the forefront of proactive foot care.

 

What’s New in Phase 2?

Phase 2 introduces PressureStat®, a cost-effective motor assessment tool designed to evaluate pressure points that might otherwise go unnoticed. This simple yet powerful tool helps identify areas at risk of developing life-threatening wounds, giving you a more comprehensive understanding of your patient's foot health.

Additionally, Vibratip™ will be added to your toolkit. Vibratip measures sensory function with consistent frequency and amplitude, outperforming traditional monofilaments and tuning forks in accuracy.

What’s Included in Your Phase 2 Kit:

  • 50 PressureStat Sheets

  • 25 CDFE Folios

  • Squeegee

  • Erasable Marker

  • Stepboard

You’ll use the PressureStat films on the same 25 patients from Phase 1, allowing you to monitor new risk areas while adding to the body of evidence from Phase 1. PressureStat also supports documentation necessary for billing a level 4 E&M during a Comprehensive Diabetic Foot Exam (CDFE).

How to Use PressureStat:

  1. Preparation: Ensure your patient is stable and can stand upright (PressureStat is not for patients with limited mobility).

  2. Set-Up: Peel off two adhesive strips and place them on the black stepboard. Remove the instruction sheet. Lift the plastic sheet and remove the white protector sheet.

  3. Assessment: Have the patient step on the prepared board. Rip back the plastic cover sheet, remove the carbon sheet back down.

  4. Documentation: Discard the carbon-like material and seal the print with the squeegee. Add the footprint, relevant results and risk information to the CDFE folio.

  5. Patient Education: Review the results with the patient, explaining areas of concern and next steps.

 

Integrating Neuropad and PressureStat:

Continue to use DermaStat, IRStat and Vibratip during every diabetic foot care visit. Neuropad and PressureStat should be assessed annually. This allows you to perform a full CDFE and ensure a thorough evaluation of your patient’s foot health.

Your continued participation in this groundbreaking study will help improve diabetic foot care for years. Thank you for being part of this important journey!