NCT00895440

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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
139

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2009

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 6, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 8, 2009

Completed
2 months until next milestone

Study Start

First participant enrolled

July 1, 2009

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
Last Updated

November 26, 2013

Status Verified

November 1, 2013

Enrollment Period

3.9 years

First QC Date

May 6, 2009

Last Update Submit

November 25, 2013

Conditions

Diabetic Neuropathy

Keywords

DiabetesDiabetic neuropathyneuropadPainless peripheral diabetic neuropathyPainful peripheral diabetic neuropathyAutonomic peripheral neuropathyCharcot neuroarthropathy

Outcome Measures

Primary Outcomes (1)

  • Identify patients with peripheral neuropathy with the Neuropad indicator test

    6 months

Study Arms (5)

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

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tameside General Hospital

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

Location

Related Publications (2)

  • Papanas N, Papatheodorou K, Papazoglou D, Monastiriotis C, Christakidis D, Maltezos E. A comparison of the new indicator test for sudomotor function (Neuropad) with the vibration perception threshold and the clinical examination in the diagnosis of peripheral neuropathy in subjects with type 2 diabetes. Exp Clin Endocrinol Diabetes. 2008 Feb;116(2):135-8. doi: 10.1055/s-2007-984455. Epub 2007 Dec 20.

    PMID: 18095233RESULT

  • Papanas N, Papatheodorou K, Christakidis D, Papazoglou D, Giassakis G, Piperidou H, Monastiriotis C, Maltezos E. Evaluation of a new indicator test for sudomotor function (Neuropad) in the diagnosis of peripheral neuropathy in type 2 diabetic patients. Exp Clin Endocrinol Diabetes. 2005 Apr;113(4):195-8. doi: 10.1055/s-2005-837735.

    PMID: 15891953RESULT

MeSH Terms

Conditions

Diabetic NeuropathiesDiabetes Mellitus

Condition Hierarchy (Ancestors)

Peripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesDiabetes ComplicationsEndocrine System DiseasesGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Edward Jude, MD, MRCP

    Tameside General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant Physician

Study Record Dates

First Submitted

May 6, 2009

First Posted

May 8, 2009

Study Start

July 1, 2009

Primary Completion

June 1, 2013

Study Completion

June 1, 2013

Last Updated

November 26, 2013

Record last verified: 2013-11

Locations

GB(1)