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ACTIVE NOT RECRUITING
NCT07674420
NA

Wearable Insoles for Recurrent Diabetic Ulcer Prevention

Sponsor: Johns Hopkins University

View on ClinicalTrials.gov

Summary

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 Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

17

Start Date

2023-10-17

Completion Date

2026-11

Last Updated

2026-06-29

Healthy Volunteers

No

Interventions

DEVICE

Orpyx Sensory Insole System

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

Locations (1)

Johns Hopkins University Hospital

Baltimore, Maryland, United States