Monitoring Physiologic Parameters in Individuals With Diabetic Peripheral Neuropathy

Orpyx Medical Technologies Inc. (Industry)
Overall Status
Recruiting ID

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Orpyx SI® Sensory Insole System

Study Design

Study Type:
Anticipated Enrollment :
50 participants
Observational Model:
Time Perspective:
Official Title:
Monitoring Physiologic Parameters in Individuals With Diabetic Peripheral Neuropathy: a Prospective Study
Actual Study Start Date :
Aug 1, 2022
Anticipated Primary Completion Date :
Feb 1, 2023
Anticipated Study Completion Date :
Mar 1, 2023

Outcome Measures

Primary Outcome Measures

  1. Frequency and location of high-pressure plantar areas [3 months]

    frequency and location of high-pressure plantar areas

  2. Change of alert frequency over time [3 months]

    change of alert frequency over time

Eligibility Criteria


Ages Eligible for Study:
18 Years to 100 Years
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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

  • Subject is willing to wear the sensory insoles and carry the digital display device all day, but for a minimum of 4.5 hours a day

  • Subject is willing to charge the Orpyx SI Sensory Insoles overnight every night

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)

  • Dementia

  • 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)

  • Extreme equinus

  • Hallux valgus

  • At the start of V1, the subject does not continue to meet the entrance criteria (inclusion and exclusion)

  • Hallux rigidus / limitus

  • Any condition that would affect or limit the ability to properly fit both shoes with the device under study

  • Subject has a history of intercurrent illness or conditions that would compromise the safety of the subject or their ability to participate in this study

  • Subject is in a site of care that is not conducive to ambulation or qualify for remote patient care (skilled nursing facility, acute care facility)

  • Amputations on the foot which require additive insole modifications (including but not limited to transmetatarsal, toe or ray amputations which create the need for a toe filler, or which prevent the subject from wearing the prescribed footwear)

Contacts and Locations


Site City State Country Postal Code
1 WAFL Inc / Cutting Edge Research Circleville Ohio United States 43113

Sponsors and Collaborators

  • Orpyx Medical Technologies Inc.


None specified.

Study Documents (Full-Text)

None provided.

More Information


None provided.
Responsible Party:
Orpyx Medical Technologies Inc. Identifier:
Other Study ID Numbers:
First Posted:
Nov 14, 2022
Last Update Posted:
Nov 17, 2022
Last Verified:
Nov 1, 2022
Studies a U.S. FDA-regulated Drug Product:
Studies a U.S. FDA-regulated Device Product:
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 17, 2022