NCT05613556

Monitoring Physiologic Parameters in Individuals With Diabetic Peripheral Neuropathy

Monitoring Physiologic Parameters in Individuals With Diabetic Peripheral Neuropathy: a Prospective Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 60 (actual)
• Sponsor: Orpyx Medical Technologies Inc. · Industry
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Diabetic Foot
• Diabetic Peripheral Neuropathy

Interventions

Type	Name	Description
DEVICE	Orpyx SI® Sensory Insole System	Orpyx SI Sensory Insole System consists of Orpyx Custom Insoles and Orpyx Sensory Technology. The Orpyx Custom Insoles are precisely fabricated for an individual's feet. The Orpyx Sensory Technology, a powered limb overload warning technology, is compatible with the Orpyx Custom Insoles. It is intended for monitoring physiological parameters, such as plantar pressure, motion and temperature, and providing real-time cues for pressure offloading as the patient goes about their daily activities

Timeline

• Start date: 2022-04-01
• Primary completion: 2023-04-23
• Completion: 2023-04-28
• First posted: 2022-11-14
• Last updated: 2023-05-09

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study