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A Study to Evaluate the Performance of VibraTip® by Different Clinical Users

NCT01878682 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2019-04-04

No results posted yet for this study

Summary

VibraTip® is a pocket-sized, wipe-clean, disposable device that provides a consistent source of gentle vibration. It has been specifically designed to overcome the limitations of tuning forks for testing the integrity of vibration sense in clinic and by the bedside. The product is a hand held device that is used to examine the feet of Diabetic patients who are susceptible to peripheral neuropathy that can in turn lead to ulcers. Treatment is expensive and can be over a period of time, often not being completely resolved, and can lead to amputation. The product will increase awareness of foot care and achieve a reduction in incidence of foot ulcers.

The study aims to evaluate the accuracy of the VibraTip device compared to the Gold Standard, the 10g Semmes Weinstein Monofilament (MF) Test, and the accuracy and usability of the VibraTip® device, as measured by different community medical practitioners.

Conditions

Sponsors & Collaborators

  • Tameside Hospital NHS Foundation Trust

    lead OTHER

Principal Investigators

  • Edward Jude, MD · Tameside Hospital NHS Foundation Trust

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-02-06
Primary Completion
2014-07-10
Completion
2014-07-10

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

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 NCT01878682 on ClinicalTrials.gov