NCT04071535

Brief 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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2015

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2015

Completed
3.7 years until next milestone

First Submitted

Initial submission to the registry

August 12, 2019

Completed
16 days until next milestone

First Posted

Study publicly available on registry

August 28, 2019

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2021

Completed
Last Updated

August 28, 2019

Status Verified

August 1, 2019

Enrollment Period

4.1 years

First QC Date

August 12, 2019

Last Update Submit

August 27, 2019

Conditions

Small Fiber NeuropathyDiabetic NeuropathiesDiabetes Mellitus

Keywords

Small fiber neuropathyDiabetic neuropathiesSkin biopsy

Outcome Measures

Primary Outcomes (1)

  • 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.

    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)

    December, 2019

Interventions

sudoscan、nerve conduction testsDEVICE

To evaluate sudomotor nerve and macrofibropathy.

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Chinese patients complaining symptoms of neuropathies after diagnosed diabetes.

You may qualify if:

  • Age ≧ 18 and ≦75 years old
  • A history of diabetes
  • Symptoms of small fiber neuropathy such as pain, paresthesia, acanthesthesia after diagnosed with diabetes

You may not qualify if:

  • Acute skin infection or injury
  • Coagulation disorders
  • History of malignant tumor
  • Usage of neurotoxic drugs
  • Alcohol abuse
  • Vascular diseases, e.g. LEASO and stroke
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

at Division of Endocrinology, the Affiliated Drum Tower Hospital of Nanjing University

Nanjing, Jiangsu, 210008, China

RECRUITING

Related Publications (2)

  • 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.

    PMID: 16190912RESULT

  • Van 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.

    PMID: 27215701RESULT

Biospecimen

Retention: SAMPLES WITH DNA

Skin sample, blood serum (approximately 3ml), and whole blood (approximately 6ml).

MeSH Terms

Conditions

Small Fiber NeuropathyDiabetic NeuropathiesDiabetes Mellitus

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Dalong Zhu, MD, PhD

CONTACT

13805150781zhudldr@gmail.com

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief Physician

Study Record Dates

First Submitted

August 12, 2019

First Posted

August 28, 2019

Study Start

December 1, 2015

Primary Completion

December 31, 2019

Study Completion

July 1, 2021

Last Updated

August 28, 2019

Record last verified: 2019-08

Locations

CN(1)