Monitoring Physiologic Parameters in Individuals With Diabetic Peripheral Neuropathy

The primary aim of this study is to use the Orpyx® SI Sensory Insole System (Orpyx Medical Technologies Inc., Calgary AB, Canada) ("Orpyx" or "the Company") as an adjunct to diabetic peripheral neuropathy standard of care (SOC), and observe step count, pressure, temperature, and adherence data through remote patient monitoring (RPM). This will provide insights into patient engagement and the benefits of offering remote, preventative care.

Inclusion Criteria:Clinically diagnosed neuropathy and type 1 or 2 diabetesQualification as a "Moderate or High-Risk Participant," as defined by the International Working Group on the Diabetic Foot (IWGDF) GuidelinesComplete healing of any previous foot ulcers, as defined by complete re-epithelialization of healed ulcer which is confirmed by two medical exams that occur at least two to three weeks apart (V0 and V1)Ability to walk independently (without use of wheelchair) for 30 stepsAged >18 yearsAbility to understand all the study and device requirements and have a life expectancy greater than the study duration0.6 < [ABI] < 1.2, capillary refill time < 5 seconds (in the last 12 months)Subject is willing and able to wear the Orpyx Sensory Insoles and provided diabetic footwear during all weight bearing activities (sitting, standing, walking, and wearing footwear)Most recent HbA1c level of < 12.0% (in the last 12 months)Subject or caregiver is able to see the bottom of their feet and inspect for redness, callus, and wounds as per standard of careSubject is willing to wear the sensory insoles and carry the digital display device all day, but for a minimum of 4.5 hours a daySubject is willing to charge the Orpyx SI Sensory Insoles overnight every nightExclusion Criteria:Active ulcer or presence of other open chronic wound (on foot or other body surface), regardless of etiology (e.g., vasculitis, neoplasms, or hematological disorders)Past history of known non-neuropathic foot ulcer (i.e., arterial or venous insufficiency ulcer)Presence of severe vascular disease (refer to acceptable ABI parameters in section 7.7.1)DementiaPsychiatric illnesses or social situations that would limit compliance with the studySerious underlying balance dysfunction, regardless of etiologySignificant cardiopulmonary or other systemic disease limiting the participant's ability to walk at least 30 steps or to stand for an amount of time equal to or greater than five (5) minutesCurrent participation in another clinical investigation of a medical device or a drug; or participation in such a study within 30 days prior to this study enrolmentCurrent osteomyelitis or gangrene of the lower extremityUncorrected plantar Charcot neuroarthropathyBunion which would predispose ulcer formation (clinician discretion)Extreme equinusHallux valgusAt the start of V1, the subject does not continue to meet the entrance criteria (inclusion and exclusion)Hallux rigidus / limitusAny condition that would affect or limit the ability to properly fit both shoes with the device under studySubject has a history of intercurrent illness or conditions that would compromise the safety of the subject or their ability to participate in this studySubject is in a site of care that is not conducive to ambulation or qualify for remote patient care (skilled nursing facility, acute care facility)Amputations on the foot which require additive insole modifications (including but not limited to transmetatarsal, toe or ray amputations which create the need for a toe filler, or which prevent the subject from wearing the prescribed footwear)