The primary aim of this study is to demonstrate the impact of the Orpyx® Sensory Insoles (Orpyx Medical Technologies Inc., Calgary AB, Canada) ("Orpyx" or "the Company") as an adjunct to the standard of care (SOC), as compared to SOC alone, on reducing plantar ulceration incidence in individuals who are at risk for developing diabetic foot complications. The secondary aims of this study are to evaluate participant quality of life, participant engagement, and economic impact, including cost-effectiveness and cost-utility. The study will also use the unique data set collected (plantar pressure, temperature, step count, movement and adherence feedback) to identify foot-loading histories that either lead to or prevent the development of ulceration in the diabetic foot.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
400
The Orpyx Sensory Insoles System uses Orpyx Sensory Technology: a powered limb overload warning technology intended for monitoring physiologic parameters, such as plantar pressure, temperature, motion, and adherence, and providing real-time cues for pressure offloading
Johns Hopkins Hospital
Baltimore, Maryland, United States
RECRUITINGPlantar ulcer recurrence
Time frame: Baseline to End of Study (12 months)
Severity of Ulcer Recurrence
Severity of ulcer recurrence will be quantified using the Society for Vascular Surgery Wound, Ischemia, and foot Infection (WIfI) classification system.
Time frame: From Baseline to End of Study Visit (12 months)
Participant quality of life
Health-related quality of life will be evaluated based on patient responses on the EuroQol- 5 Dimension (EQ-5D), Patient Interpretation of Neuropathy (PIN), and Modified Diabetic Foot-Care Behavior (MDFCB) ratings.
Time frame: These will be evaluated at Baseline, 6 months, and 12 months (end of study).
Cost-effectiveness
A prospective cost-effectiveness and cost-utility analysis will be performed comparing the experimental and control arms.
Time frame: Baseline to End of Study (12 months)
Participant engagement
For the Intervention arm only, this is measured by the number of successful interactions between the Remote Patient Monitoring (RPM) team and participant.
Time frame: Baseline to End of Study (12 months)
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