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WIREDUP: Wearable Insoles for Recurrent Diabetic Ulcer Prevention (WIREDUP)

Primary Purpose

Diabetes, Peripheral Neuropathy, Diabetic Foot

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Orpyx SI Sensory Insole System
Sponsored by
Orpyx Medical Technologies Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Diabetes focused on measuring Remote Patient Monitoring, Sensor-based Monitoring, Sensory Insoles

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Diagnosed Type 1 or 2 diabetes Clinically diagnosed neuropathy via Neuropathy Monofilament Test Qualification as a "high-risk participant," meaning a recent history (<12 months) of a healed diabetic neuropathic ulceration on the weight-bearing surface of one or both feet (this includes the plantar distal toe surface) Complete healing of any previous foot ulcers, as defined by complete re-epithelialization of that ulcer which is confirmed by two medical exams that occur at least two weeks apart (V0 and V1) Ability to walk independently (without use of wheelchair) for 30 steps. Use of a walker or cane is acceptable as long as the participant can walk for at least 30 steps. Aged >18 years Ability to understand all study requirements and have a life expectancy greater than the study duration Vascular assessment (i.e., ABI, segmental pressure) that demonstrates the participant has adequate lower extremity perfusion Subject is willing and able to maintain the required offloading (as applicable for the location of the healed ulcer) Subject is willing and able to wear the Orpyx Sensory Insoles during ambulatory activity and at home during waking hours, and for a minimum of 5 hours per day Compatibility of the device with the participant's footwear Most recent HbA1c level of < 12.0% (in the last 12 months) Amputations, if present, are compatible with the use of insoles 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) History of known non-neuropathic foot ulcer (e.g., arterial, or venous insufficiency ulcer) Presence of severe vascular disease (refer to acceptable ABI parameters in inclusion criteria) Dementia Psychiatric illness 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 study enrolment Osteomyelitis or gangrene of the lower extremity Uncorrected plantar Charcot neuroarthropathy Bunion which would predispose ulcer formation (clinician discretion) Extreme equinus Hallux valgus Hallux rigidus / limitus HbA1c levels >= 12% At the start of V1, and prior to randomization, the subject no longer meets the entrance criteria (inclusion and exclusion) 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 the study Amputations on the foot which the clinician deems incompatible with the insoles (i.e., those that require additive insole modifications)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Intervention

    Control

    Arm Description

    Outcomes

    Primary Outcome Measures

    Plantar ulcer recurrence

    Secondary Outcome Measures

    Full Information

    First Posted
    July 11, 2023
    Last Updated
    July 11, 2023
    Sponsor
    Orpyx Medical Technologies Inc.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05950659
    Brief Title
    WIREDUP: Wearable Insoles for Recurrent Diabetic Ulcer Prevention
    Acronym
    WIREDUP
    Official Title
    Prevention of Foot Ulcer Recurrence in Individuals Who Are at High-risk for Diabetic Foot Complications Using the Orpyx SI Sensory Insole System: a Multisite, Randomized, Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    January 1, 2024 (Anticipated)
    Primary Completion Date
    January 1, 2027 (Anticipated)
    Study Completion Date
    June 1, 2027 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Orpyx Medical Technologies Inc.

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    Yes
    Product Manufactured in and Exported from the U.S.
    Yes
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The primary aim of this study is to demonstrate the impact of the Orpyx® SI Sensory Insoles (Orpyx Medical Technologies Inc., Calgary AB, Canada) ("Orpyx" or "the Company") as an adjunct to the standard of care (SOC), as compared to SOC alone, on reducing plantar ulceration incidence in individuals who are at risk for developing diabetic foot complications. The secondary aims of this study are to evaluate participant quality of life, participant engagement, and economic impact, including cost-effectiveness and cost-utility. The study will also use the unique data set collected (plantar pressure, temperature, step count, movement and adherence feedback) to identify foot-loading histories that either lead to or prevent the development of ulceration in the diabetic foot.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Diabetes, Peripheral Neuropathy, Diabetic Foot, Diabetic Foot Ulcer
    Keywords
    Remote Patient Monitoring, Sensor-based Monitoring, Sensory Insoles

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    500 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Intervention
    Arm Type
    Experimental
    Arm Title
    Control
    Arm Type
    No Intervention
    Intervention Type
    Device
    Intervention Name(s)
    Orpyx SI Sensory Insole System
    Intervention Description
    The Orpyx SI Sensory Insoles System uses Orpyx Sensory Technology: a powered limb overload warning technology intended for monitoring physiologic parameters, such as plantar pressure, temperature, motion, and adherence, and providing real-time cues for pressure offloading
    Primary Outcome Measure Information:
    Title
    Plantar ulcer recurrence
    Time Frame
    12 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Diagnosed Type 1 or 2 diabetes Clinically diagnosed neuropathy via Neuropathy Monofilament Test Qualification as a "high-risk participant," meaning a recent history (<12 months) of a healed diabetic neuropathic ulceration on the weight-bearing surface of one or both feet (this includes the plantar distal toe surface) Complete healing of any previous foot ulcers, as defined by complete re-epithelialization of that ulcer which is confirmed by two medical exams that occur at least two weeks apart (V0 and V1) Ability to walk independently (without use of wheelchair) for 30 steps. Use of a walker or cane is acceptable as long as the participant can walk for at least 30 steps. Aged >18 years Ability to understand all study requirements and have a life expectancy greater than the study duration Vascular assessment (i.e., ABI, segmental pressure) that demonstrates the participant has adequate lower extremity perfusion Subject is willing and able to maintain the required offloading (as applicable for the location of the healed ulcer) Subject is willing and able to wear the Orpyx Sensory Insoles during ambulatory activity and at home during waking hours, and for a minimum of 5 hours per day Compatibility of the device with the participant's footwear Most recent HbA1c level of < 12.0% (in the last 12 months) Amputations, if present, are compatible with the use of insoles 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) History of known non-neuropathic foot ulcer (e.g., arterial, or venous insufficiency ulcer) Presence of severe vascular disease (refer to acceptable ABI parameters in inclusion criteria) Dementia Psychiatric illness 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 study enrolment Osteomyelitis or gangrene of the lower extremity Uncorrected plantar Charcot neuroarthropathy Bunion which would predispose ulcer formation (clinician discretion) Extreme equinus Hallux valgus Hallux rigidus / limitus HbA1c levels >= 12% At the start of V1, and prior to randomization, the subject no longer meets the entrance criteria (inclusion and exclusion) 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 the study Amputations on the foot which the clinician deems incompatible with the insoles (i.e., those that require additive insole modifications)

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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