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

NCT ID: NCT01878682

Last Updated: 2019-04-04

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-02-06
• Study Completion Date: 2014-07-10

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.

Detailed Description

Primary Objective 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.

Secondary Objectives The accuracy and usability of the VibraTip® device, as measured by different community medical practitioners compared to expert validation by a Diabetologist.

Prospective, single centre diagnostic evaluation. A single centre in the UK (Tameside Hospital NHS Foundation Trust). Patients will be recruited while attending Tameside Hospital NHS Foundation Trust Diabetes Clinic for a routine 12 month diabetes check up. Subjects will receive a Patient Letter to invite them to take part in the VibraTip study and a Patient Information Leaflet about the study enclosed within their Diabetes Clinic appointment. The study will aim to invite 180 patients to take part in the study and aims to recruit 100 subjects into the study within 3 months. Subjects aged 18 to 75 (inclusive) of either sex with pre-existing diabetes (Type 1 and Type 2). The study aims to recruit approximately 50 (50%) of patients with diabetic peripheral neuropathy (both painful and painless) and 50 (50%) without diabetic peripheral neuropathy. (we will go for even split if possible)

Conditions

Diabetes

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

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)

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tameside Hospital NHS Foundation Trust

OTHER

Sponsor Role: lead

Responsible Party

Dr Edward Jude

Consultant Physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Edward Jude, MD

Role: PRINCIPAL_INVESTIGATOR

Tameside Hospital NHS Foundation Trust

Locations

Tameside Hospital NHS Foundation Trust

Ashton-under-Lyne, Lancs, United Kingdom

Countries

United Kingdom

Other Identifiers

VibraTip® SSFHC/002

Identifier Type: -

Identifier Source: org_study_id