Orpyx® SI Sensory Insoles - Measure What Matters to Help Prevent DFUs

The prevention of diabetic foot ulcers (DFUs) and reducing the chances of their recurrence is paramount in maintaining the health and quality of life for patients with diabetes. We now have the ability, via a custom sensory insole, to help create a tremendous positive impact on diabetic foot complications. We can provide sensory feedback to patients and help reduce the incidence of foot ulceration by measuring the plantar pressure and temperature changes that often precede a DFU. By virtue of using this new technology, we will help improve the livelihood and lives of our patients.

Clinical Study

A randomized controlled trial was recently published in The Lancet Digital Health. The study was conducted at Manchester Metropolitan University and the Lancashire Teaching Hospital in the UK1. Dr Caroline Abbot, Dr Andrew Boulton and Dr Neil Reeves were involved in this study and utilized SurroSense Rx®, the predecessor to Orpyx SI Sensory Insoles which uses the same pressure algorithm. There were two groups, both of which received the Orpyx sensory technology. The intervention group received audio visual alerts and offloading instructions when elevated pressures were detected while the control group did not receive alerts and instructions. The primary endpoint was to assess plantar foot ulcer reoccurrence within 18 months.

The results of the RCT showed that patients receiving the real time alerts and wearing the sensory insole technology for at least 4.5 hours per day demonstrated an 86% reduction in re-ulceration. Overall, regardless of wear time, the patients in the intervention group demonstrated a 71% reduction in ulceration. Both groups showed a statistically significant reduction in DFU recurrence compared to the control group.

Download the full study: https://www.orpyx.com/clinical-study

Creating a Data-Driven Standard of Care

Causative factors need to be measured and mitigated to prevent DFUs. This needs to be done by measuring what matters in real time so the factors that cause DFU formation can be immediately addressed as the patient goes about their daily activities. 

It is well documented that pressure reduction is at the forefront of DFU prevention and that ulceration recurrence rates are 49% within the first year2. Standard of care treatments such as diabetic shoes, total contact casting, and CAM walkers, are non-interactive methods that do not provide real-time plantar pressure data. With the development of sensor technologies and remote patient monitoring for at-risk patients, we are now able to proactively adjust the patient’s care plan before ulcers occur.

The Importance of Measuring What Matters

When it comes to key points of data we need to measure, pressure and temperature cannot be compared or used interchangeably. Pressure is a causative factor that can be proactively mitigated, whereas temperature is a late-stage indicator after inflammation is present and damage has started. It lets you know there is a problem that needs to be addressed as soon as possible. However, monitoring temperature alone is not ideal in preventing DFUs.

With Orpyx SI Sensory Insoles You Can Measure What Matters

The Orpyx SI Sensory Insole System collects and analyzes key real-world data to guide the patient’s care plan:

How Orpyx SI Works

The Patient Experience

The Orpyx SI Sensory Insoles are custom insoles made based on a 3D scan of the plantar surface of the foot. The wearer places the insoles in their shoes, just like any custom orthotic. Each patient receives a digital display with cellular service, that communicates real-time pressure alerts to help shape behavior and prompt them to offload high-pressure areas that could lead to tissue damage. In addition, the patient can choose to view a simple data report including step count, hours of use and number of alerts.

The Provider Experience: A Turnkey Solution

For the first time, this real-world sensory feedback allows for the remote monitoring of a patient’s adherence, plantar pressure, temperature, and step count. This enables a new prevention management strategy for patients at risk of developing DFUs. These data are uploaded directly to a HIPAA-secure cloud dashboard where they can be viewed and used to remotely monitor a patient’s foot health between clinic visits.

Per CMS guidelines, remote patient monitoring CPT codes require general supervision by the provider3,4. This gives the provider the opportunity to develop a DFU prevention strategy with a new revenue stream while using an RPM service provider to perform the monitoring. NavCare is one such company that provides 24/7 support and a nursing team to monitor and track patient vitals to identify trends, potential problems and intervene according to the provider’s protocols. In addition, a monthly report that meets the documentation requirements for claims submission is provided.


The prevention of diabetic foot ulcers and their recurrence is of the utmost importance for the care of patients with diabetes. The randomized controlled trial above using the SOC + Orpyx technology, showed a drastic decrease in the recurrence of DFUs. When monitoring real-time physiological data, you can analyze and measure what matters while staying within the scope of what a healthcare provider is eligible to monitor. The Orpyx SI Sensory Insoles help high-risk patients stay healthy at home, avoid trips to the emergency room and generate additional revenue for healthcare providers.

  1. Abbott CA, Chatwin KE, Foden P, et al. Innovative intelligent insole system reduces diabetic foot ulcer recurrence at plantar sites: a prospective, randomised, proof-of-concept study. Lancet Digital Health. 2019 Oct;1(6):e308-e318.
  2. Armstrong DG, Boulton AJM, Bus SA. Diabetic Foot Ulcers and Their Recurrence. N Engl J Med. 2017 Jun 15;376(24):2367-2375.
  3. The reimbursement information provided is intended to provide general information concerning coding of Orpyx products only.
  4. Current Procedural Terminology (CPT®) is copyright 1966, 1970, 1973, 1977, 1981, 1983-2021 by the American Medical Association. All rights reserved. CPT is a registered trademark of the American Medical Association (AMA).