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A single centre validation/method comparison study of the experimental NERVE device for the measurement of vibration perception threshold against the established 'Neurothesiometer' device, evaluating agreement and reliability. It will also include collecting feedback from patients, carers and clinicians on the usability of the device
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Person With Diabetes | Experimental | A health care professional will conduct the vibration perception threshold testing using both the Neurothesiometer and NERVE diagnostic testing on the person with diabetes. The person with diabetes will conduct the vibration perception threshold testing using the NERVE device. There is an option for a carer/buddy to conduct the vibration perception threshold testing with the NERVE device on the person with diabetes. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Neurothesiometer | Diagnostic Test | The 'gold standard' device for Vibration Perception Threshold testing |
|
| Measure | Description | Time Frame |
|---|---|---|
| Vibration Perception Threshold (volts) as measured by Health Care Professionals | Measured using Neurothesiometer and NERVE device | Baseline |
| Vibration Perception Threshold (volts) as measured by Health Care Professionals | Measured using Neurothesiometer and NERVE device | Follow up within baseline visit |
| Vibration Perception Threshold (volts) as measured by person with diabetes | Measured using NERVE device | Baseline |
| Vibration Perception Threshold (volts) as measured by person with diabetes | Measured using NERVE device | Follow up within baseline visit |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Royal Bournemouth Hospital | Bournemouth | Dorset | BH7 7DW | United Kingdom |
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| ID | Term |
|---|---|
| D017719 | Diabetic Foot |
| ID | Term |
|---|---|
| D003925 | Diabetic Angiopathies |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D016523 | Foot Ulcer |
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| NERVE | Diagnostic Test | The experimental device for Vibration Perception Threshold testing developed by the project team |
|
| D007871 |
| Leg Ulcer |
| D012883 | Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
| D003929 | Diabetic Neuropathies |