Diabetes Foot Care Clinical Pathway - Orpyx Medical Technologies

The Canadian Institute of Health Information estimates that foot wounds (with diabetes as the leading cause) are present in 4% of all hospital inpatients, 7% of homecare clients and 10% of long-term care (LTC) residents. Of 210,000 people with diabetes in Alberta, 5,250 will seek treatment of a foot ulcer annually. In Alberta in 2014-15 there were 425 LLAs performed on 309 diabetic patients representing an increase of 89 LLA over 2010-11. Moreover, there is a tremendous reduction in quality of life of the patients and attendant negative effects on their families. The 5-year mortality rate after a new-onset diabetic foot ulcer is 43-55%, and is as high as 74% for patients undergoing LLA.

Continuous monitoring of the diabetic foot and preventative foot care is of utmost importance for patients with diabetes. This is especially the case in high risk patients who have previously had foot ulcers. Improving and standardizing diabetic foot screening, early wound detection and treatment will ultimately lead to improvements in wound prevalence, chronic wound care, and the need for surgical intervention, including amputation.

Effective pressure offloading is a key tenet of diabetic ulcer prevention and care. The effectiveness of offloading interventions is intimately linked to the skin reperfusion that is seen when persistent external pressure is alleviated. Key modifiable parameters in mitigating tissue damage to the neuropathic foot are pressure and time. Exposures from 15 min to one hour at pressures greater than 240 mmHg, and from two hours or more at pressures greater than 67 mmHg, were found to cause cell death in rat muscle tissue. Despite this, there is limited information regarding the efficacy of interventions aimed at preventing pressure ulcers; a comprehensive review of the literature did not find enough evidence to recommend a repositioning frequency. A consensus document from an international review on pressure ulcer prevention states "patients confined to wheelchairs should be taught to reposition every 15 minutes".

While established pressure offloading interventions are able to statically reduce pressure on the active ulcer, they provide no dynamic relief of pressure. Since neuropathy is characterized by a loss of protective sensation (LOPS), the patient is often unaware of sustained pressure on a specific anatomic region over time. Even with static offloading instruments, it is conceivable that critical pressure and time thresholds can be dynamically exceeded without the patient's knowledge or ability to address the problem. Taken together, the literature provides support for a system that monitors pressure over time at key locations, and provides alert-based feedback to guide as-needed, patient-based offloading for use in patients with active ulceration.

Orpyx Medical Technologies Inc. (Orpyx), has developed a smart insole technology (the "SurroSense Rx®") that senses pressure points in the user'splantar foot. This is important because pressure "hot spots" can lead to wound development that, if left untreated, can progress to a foot ulcer and LLA. Individuals able to maintain lower in-shoe peak pressures had 60% lower risk of foot ulcer recurrence. Unpublished studies with this device are demonstrating an 83% relative risk reduction in plantar ulceration in active versus control arms. This device provides dynamic offloading guidance to patients, in addition to enabling ongoing adherence tracking. This device has been shown to be an effective treatment in the management of diabetic foot patients at risk for ulcers, with respect to the care of active ulcers, in addition to prevention of future recurrence. Wearers of the SurroSense Rx® technology are provided with on demand cues for offloading, and should therefore have enhanced responsiveness and self-control over their foot care, thereby leading to a reduction in re-ulcerative events and thus, LLA.