Status:

COMPLETED

Role of Indicator Test (Neuropad) in Detecting Diabetic Neuropathy

Lead Sponsor:

Tameside Hospital NHS Foundation Trust

Conditions:

Diabetic Neuropathy

Eligibility:

All Genders

18-70 years

Brief Summary

Diabetes mellitus can result in damage to the nerves supplying the feet. Various tests can be used to assess nerve damage but no tests so far have been used to assess loss of sweating which can lead t...

Detailed Description

With increasing nervous dysfunction, the function of the sweat glands in the feet also diminishes and can cease completely. As a result the skin becomes brittle and dry, making it more susceptible to ...

Eligibility Criteria

Inclusion

  • Type 1 or type 2 diabetes
  • Age 18-70 years
  • Presence of painless neuropathy
  • Presence of painful neuropathy
  • Presence of Charcot foot

Exclusion

  • Patients with allergy to any metal
  • Peripheral vascular disease (defined as the absence of two or more foot pulses and an ankle brachial index of \< 0.8)
  • Renal failure (serum creatinine \> 130 micromol/l)
  • Foot ulceration or cellulitis or osteomyelitis
  • Patients taking drugs that affect sweating (corticosteroids, antihistamines, psychoactive drugs)
  • Chronic alcohol abuse
  • B12 deficiency (presence of anaemia, raised mean corpuscular volume, past history of abnormal B12 levels, treatment with B12)
  • Patients with any skin conditions affecting their feet(neurodermatitis, psoriasis, scleroderma, Raynaud syndrome, hyperhydrosis, acrocyanosis)

Key Trial Info

Start Date :

July 1 2009

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

June 1 2013

Estimated Enrollment :

139 Patients enrolled

Trial Details

Trial ID

NCT00895440

Start Date

July 1 2009

End Date

June 1 2013

Last Update

November 26 2013

Active Locations (1)

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1

Tameside General Hospital

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