Monitoring Physiologic Parameters in Individuals With Diabetic Peripheral Neuropathy

Inclusion criteria

• Clinically diagnosed neuropathy and type 1 or 2 diabetes
• Qualification as a "Moderate or High-Risk Participant," as defined by the International Working Group on the Diabetic Foot (IWGDF) Guidelines
• Complete 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 steps
• Aged >18 years
• Ability to understand all the study and device requirements and have a life expectancy greater than the study duration
• 0.6 < [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 care
• Subject is willing to wear the sensory insoles and carry the digital display device all day, but for a minimum of 4.5 hours a day
• Subject is willing to charge the Orpyx SI Sensory Insoles overnight every night

Exclusion 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)
• Dementia
• Psychiatric illnesses or social situations that would limit compliance with the study
• Serious underlying balance dysfunction, regardless of etiology
• Significant 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) minutes
• Current 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 enrolment
• Current osteomyelitis or gangrene of the lower extremity
• Uncorrected plantar Charcot neuroarthropathy
• Bunion which would predispose ulcer formation (clinician discretion)
• Extreme equinus
• Hallux valgus
• At the start of V1, the subject does not continue to meet the entrance criteria (inclusion and exclusion)
• Hallux rigidus / limitus
• Any condition that would affect or limit the ability to properly fit both shoes with the device under study
• Subject has a history of intercurrent illness or conditions that would compromise the safety of the subject or their ability to participate in this study
• Subject 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)