- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05613556
Monitoring Physiologic Parameters in Individuals With Diabetic Peripheral Neuropathy
May 5, 2023 updated by: Orpyx Medical Technologies Inc.
Monitoring Physiologic Parameters in Individuals With Diabetic Peripheral Neuropathy: a Prospective Study
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
60
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: E Bray
- Phone Number: +1 (855) 996-7799
- Email: emily.bray@orpyx.com
Study Locations
-
-
Ohio
-
Circleville, Ohio, United States, 43113
- WAFL Inc / Cutting Edge Research
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 100 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
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.
Description
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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Frequency and location of high-pressure plantar areas
Time Frame: 3 months
|
frequency and location of high-pressure plantar areas
|
3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 1, 2022
Primary Completion (Actual)
April 23, 2023
Study Completion (Actual)
April 28, 2023
Study Registration Dates
First Submitted
November 4, 2022
First Submitted That Met QC Criteria
November 10, 2022
First Posted (Actual)
November 14, 2022
Study Record Updates
Last Update Posted (Actual)
May 9, 2023
Last Update Submitted That Met QC Criteria
May 5, 2023
Last Verified
May 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ORPYX
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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