Wearable Insoles for Recurrent Diabetic Ulcer Prevention

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
Johns Hopkins University
Study ID
NCT07674420
Status
Active Not Recruiting

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 objective of the study is to demonstrate the clinical advantages of using the Orpyx SI Sensory Insole (SI) system as an adjunct to standard of care, as compared to standard of care alone, in reducing plantar ulceration in high-risk individuals. The investigators aim to understand participant quality of life, the economic impact and cost-effectiveness of the Orpyx SI insole system, and to evaluate participant engagement and compliance.

Key Dates

Start date
Oct 17, 2023
Status verified
Jun 2026
Primary completion
Nov 30, 2026
Completion
Nov 30, 2026

Study Design

Enrollment
17 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION

Arms

  • Experimental: Orpyx Sensory Insole System Intervention

Primary Outcome Measure

Plantar ulcer recurrence [ Time Frame: Baseline to End of Study (3 months) ]

Locations (1)

FacilityCityStateZIPSite coordinators
Johns Hopkins University HospitalBaltimoreMaryland21287-

Find similar trials in Baltimore, MD

By research site
Johns Hopkins University Hospital· Baltimore, MD

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