Role of Indicator Test (Neuropad) in Detecting Diabetic Neuropathy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dr Edward Jude, Tameside Hospital NHS Foundation Trust
ClinicalTrials.gov Identifier:
NCT00895440
First received: May 6, 2009
Last updated: November 25, 2013
Last verified: November 2013
  Purpose

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 to dry skin, fissuring and ulceration. The indicator test (Neuropad) is a plaster which is applied to the sole of the feet just below the 1st and 2nd toes of both feet. If the color of the plaster changes to pink it indicates that there is no nerve damage to the nerves. However if the plaster retains the blue color or the color only partially changes to pink after 600 seconds then this is a positive test and the patient has nerve damage.


Condition
Diabetic Neuropathy

Study Type: Observational
Study Design: Time Perspective: Cross-Sectional
Official Title: Neuropad Test for Detection of Sudomotor Dysfunction in Patients With Painful and Painless Diabetic Neuropathy and Charcot Neuroarthropathy

Resource links provided by NLM:


Further study details as provided by Tameside Hospital NHS Foundation Trust:

Primary Outcome Measures:
  • Identify patients with peripheral neuropathy with the Neuropad indicator test [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment: 139
Study Start Date: July 2009
Study Completion Date: June 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
Diabetic patients without neuropathy
2
Diabetic patients with painless neuropathy
3
Diabetic patients with painful neuropathy
4
Diabetic patients with Charcot neuroarthropathy
5
Control non-diabetic subjects

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 fissuring and breakdown leading to foot ulceration. This is where the diagnosis using the Neuropad plaster might be useful. The Neuropad measures sweat production and have been proposed as a new test of neuropathy (8,9). The Neuropad examines the function of the sweat glands by means of a colour indicator. The indicator test enables the diagnosis of neuropathy in a substantial proportion of patients with normal clinical examination (10).

This colour indicator, a cobalt-II-salt, is applied in the form of a plaster to the area of skin on the patient's foot to be examined. In healthy subjects, the moisture (sweat) on the foot changes the colour of the Neuropad plaster from blue to pink normally within minutes. However, if the colour does not change completely or very slowly, this indicates initial nerve damage. This test is, as yet, the only one that examines changes in moistness of the foot. The speed and scale of the colour change of the Neuropad plaster can then be assessed as indicators of sudomotor function and thus as indicators of diabetic neuropathy as well. Although the test has been done in patients with diabetic neuropathy it has not been used as a discriminator in painless and painful neuropathy, or in patients with Charcot neuroarthropathy.

In this study we aim to assess the presence of sudomotor dysfunction in patients with painful and painless neuropathy and patients with Charcot foot.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Type 1 and type 2 diabetic patients with and without peripheral neuropathy (painless and painful) and Charcot neuroarthropathy; and non-diabetic subjects

Criteria

Inclusion Criteria:

  1. Type 1 or type 2 diabetes
  2. Age 18-70 years
  3. Presence of painless neuropathy
  4. Presence of painful neuropathy
  5. Presence of Charcot foot

Exclusion Criteria:

  1. Patients with allergy to any metal
  2. Peripheral vascular disease (defined as the absence of two or more foot pulses and an ankle brachial index of < 0.8)
  3. Renal failure (serum creatinine > 130 micromol/l)
  4. Foot ulceration or cellulitis or osteomyelitis
  5. Patients taking drugs that affect sweating (corticosteroids, antihistamines, psychoactive drugs)
  6. Chronic alcohol abuse
  7. B12 deficiency (presence of anaemia, raised mean corpuscular volume, past history of abnormal B12 levels, treatment with B12)
  8. Patients with any skin conditions affecting their feet(neurodermatitis, psoriasis, scleroderma, Raynaud syndrome, hyperhydrosis, acrocyanosis)
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00895440

Locations
United Kingdom
Tameside General Hospital
Ashton-under-Lyne, Lancashire, United Kingdom, OL69RW
Sponsors and Collaborators
Tameside Hospital NHS Foundation Trust
Investigators
Principal Investigator: Edward Jude, MD, MRCP Tameside General Hospital
  More Information

Publications:
Responsible Party: Dr Edward Jude, Consultant Physician, Tameside Hospital NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT00895440     History of Changes
Other Study ID Numbers: Neuropad01
Study First Received: May 6, 2009
Last Updated: November 25, 2013
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by Tameside Hospital NHS Foundation Trust:
Diabetes
Diabetic neuropathy
neuropad
Painless peripheral diabetic neuropathy
Painful peripheral diabetic neuropathy
Autonomic peripheral neuropathy
Charcot neuroarthropathy

Additional relevant MeSH terms:
Diabetic Neuropathies
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases

ClinicalTrials.gov processed this record on August 21, 2014