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Wearable Insoles for Recurrent Diabetic Ulcer Prevention

NCT07674420 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 17

Last updated 2026-07-14

No results posted yet for this study

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 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.

Conditions

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

Sponsors & Collaborators

Principal Investigators

  • Caitlyn Hicks, MD · Johns Hopkins University

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-10-17
Primary Completion
2026-11-30
Completion
2026-11-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07674420 on ClinicalTrials.gov