The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT05613556
Recruitment Status : **RECRUITING NOW**
First Posted : November 11, 2022
Last Update Posted : November 11, 2022
Sponsor:
Information provided by (Responsible Party):
Orpyx Medical Technologies Inc.
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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.
Diabetic Foot Diabetic Peripheral Neuropathy
Device: Orpyx SI® Sensory Insole System
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Study Type :
Observational
Estimated Enrollment :
50 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Monitoring Physiologic Parameters in Individuals With Diabetic Peripheral Neuropathy: a Prospective Study
Actual Study Start Date :
August 1, 2022
Estimated Primary Completion Date :
February 2023
Estimated Study Completion Date :
March 2023
Resource links provided by the National Library of Medicine
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Intervention Details:
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
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Primary Outcome Measures :
frequency and location of high-pressure plantar areas [ Time Frame: 3 months ]
frequency and location of high-pressure plantar areas and change of alert frequency over time.
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Information from the National Library of Medicine
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
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Ages Eligible for Study: Â
18 Years to 100 Years  (Adult, Older Adult)
Sexes Eligible for Study: Â
All
Accepts Healthy Volunteers: Â
No
Sampling Method: Â
Non-Probability Sample
The participant population to be studied will be subjects 18 years of age or older who have been diagnosed with diabetes (Type I or Type II) and neuropathy and who are at moderate to high risk of foot ulceration based on the International Working Group on the Diabetic Foot (IWDGF) guidelines.
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)
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Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05613556
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WAFL Inc / Cutting Edge Research
Circleville, Ohio, United States, 43113
Contact: Brock Liden, DPM Â Â Â Â Â Â
Principal Investigator: Brock Liden, DPM Â Â Â Â Â Â
Orpyx Medical Technologies Inc.
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Responsible Party:
Orpyx Medical Technologies Inc.
ClinicalTrials.gov Identifier:
NCT05613556 Â Â
Other Study ID Numbers:
ORPYX
First Posted:
November 11, 2022 Â Â Key Record Dates
Last Update Posted:
November 11, 2022
Last Verified:
November 2022
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Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Additional relevant MeSH terms:
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Peripheral Nervous System DiseasesDiabetic NeuropathiesDiabetic FootNeuromuscular DiseasesNervous System DiseasesDiabetic AngiopathiesVascular DiseasesCardiovascular Diseases
Foot UlcerLeg UlcerSkin UlcerSkin DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System Diseases
Source: View full study details on ClinicalTrials.gov
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. By listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
