Prevention of Foot Ulcer Recurrence in Individuals Who Are at High-risk for Diabetic Foot Complications Using the Orpyx Sensory Insole System: a Multisite, Randomized, Controlled Trial

Orpyx Medical Technologies Inc.0 sites400 target enrollmentApril 1, 2025

ConditionsDiabetes Peripheral Neuropathy Diabetic Foot Diabetic Foot Ulcer

Overview

Phase: N/A
Intervention: Not specified
Conditions: Diabetes
Sponsor: Orpyx Medical Technologies Inc.
Enrollment: 400
Primary Endpoint: Plantar ulcer recurrence
Status: Not Yet Recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

The primary aim of this study is to demonstrate the impact of the Orpyx® 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.

Registry

clinicaltrials.gov

Start Date

April 1, 2025

End Date

January 1, 2028

Last Updated

last year

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Orpyx Medical Technologies Inc.

Responsible Party

Sponsor

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

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)
•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)