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

Orpyx Medical Technologies Inc.1 site in 1 country60 target enrollmentApril 1, 2022

ConditionsDiabetic Foot Diabetic Peripheral Neuropathy

Overview

Phase: N/A
Intervention: Not specified
Conditions: Diabetic Foot
Sponsor: Orpyx Medical Technologies Inc.
Enrollment: 60
Locations: 1
Primary Endpoint: Frequency and location of high-pressure plantar areas
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

April 1, 2022

End Date

April 28, 2023

Last Updated

2 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Orpyx Medical Technologies Inc.

Responsible Party

Sponsor

Eligibility Criteria

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

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)
•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)