Ignite Creation Date:
2025-12-24 @ 11:33 PM
Ignite Modification Date:
2026-01-01 @ 5:44 AM
Study NCT ID:
NCT05613556
Status:
COMPLETED
Last Update Posted:
2023-05-09
First Post:
2022-11-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Monitoring Physiologic Parameters in Individuals With Diabetic Peripheral Neuropathy
Sponsor:
Orpyx Medical Technologies Inc.
Organization:
Study Overview
Official Title:
Monitoring Physiologic Parameters in Individuals With Diabetic Peripheral Neuropathy: a Prospective Study
Status:
COMPLETED
Status Verified Date:
2023-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: