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

NCT01878682 | Completed

• 1 other identifier: VibraTip® SSFHC/002
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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

Diabetes

Outcome Measures

Primary Outcomes (1)

• The accuracy of the VibraTip® device, as measured by a comparison with the Gold Standard, the 10g Semmes Weinstein Monofilament (MF) Test by a Diabetologist.

  The accuracy of the VibraTip® device, as measured by a comparison with the Gold Standard, the 10g Semmes Weinstein Monofilament (MF) Test by a Diabetologist.

  3 months

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients will be recruited while attending Tameside Hospital NHS Foundation Trust Diabetes Clinic for a routine 12 month diabetes check up

You may qualify if:

• Subjects aged 18 to 75 (inclusive) of either sex Subjects from whom consent has been obtained Subjects with pre-existing diabetes (Type 1 and Type 2)

You may not qualify if:

• Subjects unable to give consent
• Subjects aged less than 18 years or over 75 years
• Subjects with non-diabetic causes of neuropathy
• Subjects who have already taken part in the study
• Subjects who have active foot ulceration on the big toe
• Subjects who have PAD ABPI \< 0.7

Sponsors & Collaborators

• Tameside Hospital NHS Foundation Trust: lead

Study Sites (1)

Tameside Hospital NHS Foundation Trust

Ashton-under-Lyne, Lancs, OL69RW, United Kingdom

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Edward Jude, MD

  Tameside Hospital NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant Physician

Study Record Dates

• First Submitted: June 8, 2013
• First Posted: June 17, 2013
• Study Start: February 6, 2014
• Primary Completion: July 10, 2014
• Study Completion: July 10, 2014
• Last Updated: April 4, 2019

Record last verified: 2019-04

Locations

GB (1)