Smart Diabetic Foot Stabilization and Off-loading System* to Treat Diabetic Foot Ulcers (DFUs)

Every 20 seconds a lower limb is amputated due to diabetic complications. 

The total medical cost for the management of diabetic foot in the United States exceeds $17.5B, in addition to the cost for management of diabetes.1 Clinicians know that proper DFU treatment is predicated in mechanical off-loading as the cornerstone in ulcers with increased biomechanical stress. 

However, subjects with DFUs wear their offloading devices for only 28% of daily steps. 

Therefore, treatment failure is the norm.4,5   

There is strong evidence that uncomplicated plantar ulcers can be healed in 8 to 12 weeks.  Yet current “standard of care” in US clinical trials have a 76% treatment failure rate at 12 weeks.  “We believe that inadequate use of off-loading explains this difference.”6 Our system comprised of proprietary hardware sensors and software monitors patient adherence to weight offloading but also daily, weekly and monthly patient activity.  It provides sensor driven data that can be combined with patient self-reported data. 

Our dedicated microelectronic device, mobile application with alert system and a web dashboard inform the patient and the caregiver of non-adherence, allowing for a quantified, more meaningful patient-clinician interaction, and potential escalation of care.  The diabetic foot stabilization product is registered as a class one FDA cleared medical device. 

According to the International Working Group on the Diabetic Foot (IWGDF), our device is the new gold standard by the guidelines issued in 2019 at the International Symposium on the Diabetic Foot.7  This is the first smart footwear system designed from the ground up to provide quantified adherence and activity related data, and at the same time improve Patient – Clinician interaction.  When made non-removable its efficacy is on par with the total contact cast (TCC).  Thanks to the new CPT codes and our system, clinicians may be reimbursed a fixed amount per patient per month for remote patient monitoring.