Wearable Insoles for Recurrent Diabetic Ulcer Prevention

Wearable Insoles for Recurrent Diabetic Ulcer Prevention

The primary objective of the study is to demonstrate the clinical advantages of using the Orpyx SI Sensory Insole (SI) system as an adjunct to standard of care in reducing plantar ulceration in high-risk individuals. The investigators aim to understand participant quality of life, the economic impact and cost-effectiveness of the Orpyx SI insole system, and to evaluate participant engagement and compliance.

Inclusion Criteria:

• Diagnosed Type 1 or 2 diabetes
• Clinically diagnosed neuropathy via Neuropathy Monofilament Test (Appendix A)
• Qualification as a "high-risk participant," meaning a recent history (<12 months) of a healed diabetic neuropathic ulceration on the weight-bearing surface of one or both feet (this includes the plantar distal toe surface)
• Complete healing of any previous foot ulcers, as defined by complete re-epithelialization of that ulcer which is confirmed by two medical exams that occur at least two weeks apart (screening visit and baseline study visit)
• Ability to walk independently (without use of wheelchair) for 30 steps. Use of a walker or cane is acceptable as long as the participant can walk for at least 30 steps.
• Aged >18 years
• Ankle-Brachial Index (ABI) > 0.6 or Toe-Brachial Index (TBI) > 0.4 or palpable pulses or evidence of healing in the last 2 months. If ABI < 0.4, the patient's vascular lab studies (ABI, TBI, pulse volume recordings) will be reviewed by the study Principal Investigator and a Co-Investigator vascular surgeon
• Subject is willing and able to maintain the required offloading (as applicable for the location of the healed ulcer)
• Subject is willing and able to wear the Orpyx Sensory Insoles during ambulatory activity and at home during waking hours, and for a minimum of 5 hours per day
• Amputations, if present, are compatible with the use of insoles at physician discretion (e.g. Transmetatarsal Amputation (TMA) are acceptable)

Exclusion Criteria:

• Active ulcer or presence of other open chronic wound (on foot or leg), regardless of etiology (e.g., vasculitis, neoplasms, or hematological disorders)
• Dementia
• Psychiatric illness or social situations that would limit compliance with the study
• Significant cardiopulmonary, severe imbalance, 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 (self-reported)
• Current participation in another clinical investigation of a similar medical device designed to offload or prevent diabetic foot ulcer formation; or participation in such a study within 30 days prior to study enrollment, per physician discretion
• Current enrollment in any other remote patient pedal monitoring (RPPM) program
• Osteomyelitis or gangrene of the lower extremity
• Uncorrected plantar Charcot neuroarthropathy
• Bunion which would predispose ulcer formation (clinician discretion)
• Extreme equinus
• At the start of V1, and prior to randomization, the subject no longer meets the entrance criteria (inclusion and exclusion)
• Above ankle amputation
• Amputations not compatible with the insole, per physician discretion
• Foot deformities or amputations that require surgical intervention as the next step in standard of care, and that the study footwear and device would not adequately address (to be adjudicated by an outside review panel).
• Brannock-measured foot size > Men's 14 (Women's 12)
• Physician discretion