WIREDUP: Wearable Insoles for Recurrent Diabetic Ulcer Prevention

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
Johns Hopkins University
Study ID
NCT05950659
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Orpyx Sensory Insole System — DEVICE
    The Orpyx 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

Study Details

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.

Key Dates

Start date
Apr 22, 2026
Status verified
Jun 2026
Primary completion
Apr 1, 2029
Completion
Apr 1, 2029

Study Design

Enrollment
400 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION

Arms

  • Experimental: Intervention
  • No Intervention: Control

Primary Outcome Measure

Plantar ulcer recurrence [ Time Frame: Baseline to End of Study (12 months) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Johns Hopkins HospitalBaltimoreMaryland21287
Shannon Hammerlund, MPH
[email protected]
667-306-9479

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By research site
Johns Hopkins Hospital· Baltimore, MD

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