Diabetic NeuropathyNCT00895440
Role of Indicator Test (Neuropad) in Detecting Diabetic Neuropathy
An observational study of Diabetic Neuropathy, run by Tameside Hospital NHS Foundation Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetic Neuropathy
- How many people
- 139 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jul 2009to Jun 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Type 1 and type 2 diabetic patients with and without peripheral neuropathy (painless and painful) and Charcot neuroarthropathy; and non-diabetic subjects
Who may be able to join
- Type 1 or type 2 diabetes
- Age 18-70 years
- Presence of painless neuropathy
- Presence of painful neuropathy
- Presence of Charcot foot
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Tameside General Hospital
Ashton-under-Lyne, Lancashire, OL69RW
About this study
Official title: Neuropad Test for Detection of Sudomotor Dysfunction in Patients With Painful and Painless Diabetic Neuropathy and Charcot Neuroarthropathy
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.
Read the 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.
- Conditions
- Diabetic Neuropathy
- Keywords
- Diabetes, Diabetic neuropathy, neuropad, Painless peripheral diabetic neuropathy, Painful peripheral diabetic neuropathy, Autonomic peripheral neuropathy, Charcot neuroarthropathy
- Medical subject headings
- Diabetic Neuropathies, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identify patients with peripheral neuropathy with the Neuropad indicator test
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2009 (estimated)
- Study startJul 2009
- Primary completionJun 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Diabetic NeuropathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Cross-sectional
- Enrolment
- 139 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tameside Hospital NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Edward Jude, Tameside Hospital NHS Foundation Trust
- Investigators
- Edward Jude, MD, MRCP, Principal investigator, Tameside General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00895440
- Sponsor's protocol ID
- Neuropad01
- Status last verified
- Nov 2013
- First submitted
- 6 May 2009
- Last updated
- 26 Nov 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 18095233Papanas 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.
PubMed 15891953
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuropad Test for Detection of Sudomotor Dysfunction in Patients With Painful and Painless Diabetic Neuropathy and Charcot Neuroarthropathy
- ClinicalTrials.gov ID
- NCT00895440
- Acronym / sponsor ID
- Neuropad01
- Conditions
- Diabetic Neuropathy
- Keywords
- Diabetes, Diabetic neuropathy, neuropad, Painless peripheral diabetic neuropathy, Painful peripheral diabetic neuropathy, Autonomic peripheral neuropathy, Charcot neuroarthropathy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 139 participants (actual)
- Lead sponsor
- Tameside Hospital NHS Foundation TrustUniversity, hospital or other
- Study start
- Jul 2009
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 8 May 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Time perspective
- Cross-sectional
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Type 1 and type 2 diabetic patients with and without peripheral neuropathy (painless and painful) and Charcot neuroarthropathy; and non-diabetic subjects
Key inclusion criteria (5 listed)
- Type 1 or type 2 diabetes
- Age 18-70 years
- Presence of painless neuropathy
- Presence of painful neuropathy
- Presence of Charcot foot
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Identify patients with peripheral neuropathy with the Neuropad indicator test
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2013.
- Results publication: PubMed 18095233Papanas 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.
- Results publication: PubMed 15891953Papanas 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Edward Jude, MD, MRCP principal investigator
Tameside General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetic Neuropathy, run by Tameside Hospital NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identify patients with peripheral neuropathy with the Neuropad indicator test (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00895440, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Nov 2013.