Small Fiber NeuropathyNCT04071535
Skin Biopsy in the Diagnosis of Small Fiber Neuropathy in Chinese Patients With Diabetes
An observational study of Small Fiber Neuropathy and Diabetic Neuropathies, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School at 1 site in China.
Trial summary
To detect small fiber neuropathy in patients with possible or established diabetic peripheral neuropathy (DPN) by skin biopsy and explore clinical characteristics and pathological features in Chinese patients with diabetes. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Small Fiber Neuropathy, Diabetic Neuropathies, Diabetes Mellitus
- What is being tested?
- sudoscan、nerve conduction tests
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2015to 1 Jul 2021
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Chinese patients complaining symptoms of neuropathies after diagnosed diabetes.
Who may be able to join
- Age ≧ 18 and ≦75 years old
- A history of diabetes
- Symptoms of small fiber neuropathy such as pain, paresthesia, acanthesthesia after diagnosed with diabetes
Who cannot join
- Acute skin infection or injury
- Coagulation disorders
- History of malignant tumor
- Usage of neurotoxic drugs
- Alcohol abuse
- Vascular diseases, e.g. LEASO and stroke
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- Infectious diseases, e.g. hepatitis B, HIV, and syphilis
- Metabolic disorders, e.g. hypothyroidism, hyperlipidemia, and amyloid lesions
- Connective tissue diseases
- Nutritional disorders, e.g.vitamin B6 deficiency, and vitamin B12 deficiency
- Other causes of peripheral neuropathy, e.g. lumbar disc herniation, Guillain-Barre Syndrome, and polyradiculopathy
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
at Division of Endocrinology, the Affiliated Drum Tower Hospital of Nanjing University
Nanjing, Jiangsu, 210008
Dalong Zhu, MD,PhD, 86-25-83-105302, zhudldr@gmail.com
Yan Bi, MD,PhD, 86-25-83-105302, biyan@nju.edu.cn
About this study
Official title: Application of Skin Biopsy in the Early Diagnosis of Small Fiber Neuropathy in Chinese Patients With Diabetes
To detect small fiber neuropathy in patients with possible or established diabetic peripheral neuropathy (DPN) by skin biopsy and explore clinical characteristics and pathological features in Chinese patients with diabetes.
Read the detailed description
Small fiber neuropathy (SFN) is a subtype of diabetic neuropathy, patients with SFN often manifest as paresthesia of warmth, cold, pinprick and so on, especially affect ed length-dependent area. Skin biopsy is an effective method to diagnose SFN with high diagnostic accuracy. The procedure is simple and minimally, and the wound usually heals within a few days. However, skin biopsy is not widely used in diagnose of SFN in Chinese patients with diabetes. This study is aimed to establish a normal reference range of intraepidermal nerve fiber density (IENFD) in the Chinese population, and to detect SFN in Chinese patients with diabetes by skin biopsy.
- Being tested
- sudoscan、nerve conduction tests
- Keywords
- Small fiber neuropathy, Diabetic neuropathies, Skin biopsy
- Medical subject headings
- Small Fiber Neuropathy, Diabetic Neuropathies, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sudoscan、nerve conduction testsDevice
To evaluate sudomotor nerve and macrofibropathy.
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of small fiber neuropathy in Chinese patients with diabetes by calculating intraepidermal nerve fiber density (IENFD) via skin biopsy
Calculating intraepidermal nerve fiber density (IENFD) is considered as as gold criteria of diagnosis of small fiber neuropathy.
Measured: December, 2019
Secondary outcomes (1)
Evaluation of diagnostic sensitivity and specificity of sudoscan in Chinese diabetic patients with small fiber neuropathy compared with intraepidermal nerve fiber density (IENFD)
Sudoscan is used to as an autonomic nerve assessment tool with objective and stable operations, which measures the function of sweat glands by stimulating a low voltage current ( < 4 volts) and detects the electrochemical reaction between the electrodes and chloride ions in both hands and feet. Results are presented as electrochemical skin conductance in hands (HESC) and feet (FESC), asymmetry ratio value in hands (HASYM) and feet (FASYM). We use intraepidermal nerve fiber density (IENFD) measured by skin biopsy as the gold standard, sudoscan is used to evaluate its diagnostic efficiency including sensitivity and specificity of small fiber neuropathy.
Measured: December, 2019
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2019
- Study start1 Dec 2015
- Primary completion31 Dec 2019 (estimated)
- Study completion1 Jul 2021 (estimated)
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 Small Fiber NeuropathyStudies of the same condition, open and under way.
- More trials run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolThe sponsor's other registered studies.
- 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
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dalong Zhu, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04071535
- Sponsor's protocol ID
- SFNChinaDM
- Status last verified
- Aug 2019
- First submitted
- 12 Aug 2019
- Last updated
- 28 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The demographic and biochemical indicators of this study.
Publications
Lauria G, Cornblath DR, Johansson O, McArthur JC, Mellgren SI, Nolano M, Rosenberg N, Sommer C; European Federation of Neurological Societies. EFNS guidelines on the use of skin biopsy in the diagnosis of peripheral neuropathy. Eur J Neurol. 2005 Oct;12(10):747-58. doi: 10.1111/j.1468-1331.2005.01260.x.
PubMed 16190912Van Acker N, Rage M, Sluydts E, Knaapen MW, De Bie M, Timmers M, Fransen E, Duymelinck C, De Schepper S, Anand P, Meert T, Plaghki L, Cras P. Automated PGP9.5 immunofluorescence staining: a valuable tool in the assessment of small fiber neuropathy? BMC Res Notes. 2016 May 23;9:280. doi: 10.1186/s13104-016-2085-4.
PubMed 27215701
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of Skin Biopsy in the Early Diagnosis of Small Fiber Neuropathy in Chinese Patients With Diabetes
- ClinicalTrials.gov ID
- NCT04071535
- Acronym / sponsor ID
- SFNChinaDM
- Keywords
- Small fiber neuropathy, Diabetic neuropathies, Skin biopsy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolUniversity, hospital or other
- Study start
- 1 Dec 2015 (actual)
- Primary completion
- 31 Dec 2019 (estimated)
- Study completion
- 1 Jul 2021 (estimated)
- First posted
- 28 Aug 2019 (actual)
- 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.
To detect small fiber neuropathy in patients with possible or established diabetic peripheral neuropathy (DPN) by skin biopsy and explore clinical characteristics and pathological features in Chinese patients with diabetes.
Detailed description
Small fiber neuropathy (SFN) is a subtype of diabetic neuropathy, patients with SFN often manifest as paresthesia of warmth, cold, pinprick and so on, especially affect ed length-dependent area. Skin biopsy is an effective method to diagnose SFN with high diagnostic accuracy. The procedure is simple and minimally, and the wound usually heals within a few days. However, skin biopsy is not widely used in diagnose of SFN in Chinese patients with diabetes. This study is aimed to establish a normal reference range of intraepidermal nerve fiber density (IENFD) in the Chinese population, and to detect SFN in Chinese patients with diabetes by skin biopsy.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Chinese patients complaining symptoms of neuropathies after diagnosed diabetes.
Key inclusion criteria (3 listed)
- Age ≧ 18 and ≦75 years old
- A history of diabetes
- Symptoms of small fiber neuropathy such as pain, paresthesia, acanthesthesia after diagnosed with diabetes
Key exclusion criteria (11 listed)
- Acute skin infection or injury
- Coagulation disorders
- History of malignant tumor
- Usage of neurotoxic drugs
- Alcohol abuse
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| sudoscan、nerve conduction testsTo evaluate sudomotor nerve and macrofibropathy. | Device | – |
Primary outcome
Assessment of small fiber neuropathy in Chinese patients with diabetes by calculating intraepidermal nerve fiber density (IENFD) via skin biopsy
Time frame: December, 2019
Calculating intraepidermal nerve fiber density (IENFD) is considered as as gold criteria of diagnosis of small fiber neuropathy.
1 secondary outcome
Evaluation of diagnostic sensitivity and specificity of sudoscan in Chinese diabetic patients with small fiber neuropathy compared with intraepidermal nerve fiber density (IENFD)
Time frame: December, 2019
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2019.
- Results publication: PubMed 16190912Lauria G, Cornblath DR, Johansson O, McArthur JC, Mellgren SI, Nolano M, Rosenberg N, Sommer C; European Federation of Neurological Societies. EFNS guidelines on the use of skin biopsy in the diagnosis of peripheral neuropathy. Eur J Neurol. 2005 Oct;12(10):747-58. doi: 10.1111/j.1468-1331.2005.01260.x.
- Results publication: PubMed 27215701Van Acker N, Rage M, Sluydts E, Knaapen MW, De Bie M, Timmers M, Fransen E, Duymelinck C, De Schepper S, Anand P, Meert T, Plaghki L, Cras P. Automated PGP9.5 immunofluorescence staining: a valuable tool in the assessment of small fiber neuropathy? BMC Res Notes. 2016 May 23;9:280. doi: 10.1186/s13104-016-2085-4.
- Individual participant dataSharing planned: Undecided. The demographic and biochemical indicators of this study.
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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.
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 Small Fiber Neuropathy and Diabetic Neuropathies, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School at 1 site in China.
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 3 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 28 Aug 2019. 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dalong Zhu, MD, PhD (13805150781, zhudldr@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of small fiber neuropathy in Chinese patients with diabetes by calculating intraepidermal nerve fiber density (IENFD) via skin biopsy (time frame: December, 2019). 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 NCT04071535, 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 28 Aug 2019.