Diabetic FootNCT05613556
Monitoring Physiologic Parameters in Individuals With Diabetic Peripheral Neuropathy
An observational study of Diabetic Foot and Diabetic Peripheral Neuropathy, run by Orpyx Medical Technologies Inc. at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Diabetic Foot, Diabetic Peripheral Neuropathy
- What is being tested?
- Orpyx SI® Sensory Insole System
- Type of treatment
- Medical device
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2022to 28 Apr 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
WAFL Inc / Cutting Edge Research
Circleville, Ohio, 43113
About this study
Official title: 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.
- Conditions
- Diabetic Foot, Diabetic Peripheral Neuropathy
- Being tested
- Orpyx SI® Sensory Insole System
- Medical subject headings
- Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Orpyx SI® Sensory Insole SystemDevice
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
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency and location of high-pressure plantar areas
frequency and location of high-pressure plantar areas
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2022
- Study start1 Apr 2022
- Primary completion23 Apr 2023
- Study completion28 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic FootStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Orpyx Medical Technologies Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05613556
- Sponsor's protocol ID
- ORPYX
- Status last verified
- May 2023
- First submitted
- 4 Nov 2022
- Last updated
- 9 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Monitoring Physiologic Parameters in Individuals With Diabetic Peripheral Neuropathy: a Prospective Study
- ClinicalTrials.gov ID
- NCT05613556
- Acronym / sponsor ID
- ORPYX
- Conditions
- Diabetic Foot, Diabetic Peripheral Neuropathy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Orpyx Medical Technologies Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 23 Apr 2023 (actual)
- Study completion
- 28 Apr 2023 (actual)
- First posted
- 14 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (19 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Orpyx SI® Sensory Insole SystemOrpyx 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 | Device | – |
Primary outcome
Frequency and location of high-pressure plantar areas
Time frame: 3 months
frequency and location of high-pressure plantar areas
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2023.
- Individual participant dataSharing planned: No
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Evaluation of Personalized Nutritional Intervention on Wound Healing of Cutaneous Ulcers in Diabetics
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetic Foot and Diabetic Peripheral Neuropathy, run by Orpyx Medical Technologies Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency and location of high-pressure plantar areas (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2023.