UMIN-CTR Clinical Trial

Recruitment status Terminated
Unique ID issued by UMIN UMIN000006639
Receipt No. R000007752
Scientific Title A study of small fiber neuropathy (SFN): immunohistochemical changes of peripheral nerve fibers on biposied skin and correlation with inflammatory cytokine expression
Date of disclosure of the study information 2011/11/01
Last modified on 2019/11/13 (Ver. 4)

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Basic information
Public title A study of small fiber neuropathy (SFN): immunohistochemical changes of peripheral nerve fibers on biposied skin and correlation with inflammatory cytokine expression
Acronym A study of small fiber neuropathy (SFN)
Scientific Title A study of small fiber neuropathy (SFN): immunohistochemical changes of peripheral nerve fibers on biposied skin and correlation with inflammatory cytokine expression
Scientific Title:Acronym A study of small fiber neuropathy (SFN)
Region
Japan

Condition
Condition small fiber neuropathy
Classification by specialty
Neurology Dermatology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Small fiber neuropathy (SFN) is a distrubance of peripheral nerves expressing burning pain and painful dysesthesias in the distal extremities without apparent nerve conduction abnormality, frequently associated with diabetes mellitus, collagen diseases, vasculitis, sarcoidosis and other systemic diseases. It has been reported that SFN is a disturbance of c-fibers or Adelta-fibers conducting mainly noxious signals and distributing in the dermis and epidermis of the skin. However pathomechanism of SFN has not been fully documented, although clinical needs to establish adequate therapeutic strategy are required.
This study is designed to investigate immunohistochemical change of peripheral nerves in biopsied skin in relation with clinically evaluated SFN in patients with diabetes mellitus, collagen diseases, vasculitis and sarcoidosis. Inflammatory cytokines in the same tissues, as well as in the venous blood, are investigated in order to correlate the change of peripheral nerves with the systemic and cutaneous immunological and inflammatory background.
Basic objectives2 Bio-equivalence
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes Epidermal nerve fiber density
Immunohistochemical reactivity alteration in dermal and epidermal nerve fibers
Cytokine expression in biopsied skin in protein and mRNA levels
Key secondary outcomes Morphological change in dermal and epidermal nerve fibers
Cytokine expression in the peripheral blood in protein and mRNA levels

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
15 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients suffered from diabetes mellitus, collagen diseases, vasculitis and sarcoidosis accompanied with subjective symptoms such as chronic pain, dysaesthesia, and/or disturbed temperature sensitivity are to be included. Patients are neurophysiologically and electrophysiologically diagnosed and classified as possessing SFN, or not having SFN but with disturbance of peripheral nerves with greater diameter.
Key exclusion criteria Patients diagnosed as not having SFN or other type of disturbance of peripheral nerves with greater diameter, or patients with disagreement are to be excluded from the study. .
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Seiichi Izaki, MD, PhD
Organization Saitama Medical Center, Saitama Medical University
Division name Department of Dermatology
Zip code
Address 1981 Kamoda, Kawagoe, Saitama, Japan
TEL 049-228-3652
Email izks1@saitama-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Seiichi Izaki, MD, PhD
Organization Saitama Medical Center, Saitama Medical University
Division name Department of Dermatology
Zip code
Address Department of Dermatology
TEL 049-228-3652
Homepage URL
Email izks1@saitama-med.ac.jp

Sponsor
Institute Department of Dermatology
Saitama Medical Center, Saitama Medical University
Institute
Department

Funding Source
Organization Department of Dermatology
Saitama Medical Center, Saitama Medical University
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 埼玉医科大学総合医療センター (埼玉県)

Other administrative information
Date of disclosure of the study information
2011 Year 11 Month 01 Day

Related information
URL releasing protocol Unpublished
Publication of results Unpublished

Result
URL related to results and publications Unpublished
Number of participants that the trial has enrolled 3
Results 
Participants are not sufficiently enrolled before the retirement date of this investigator, resulting in withdrawal of this  investigation.
Results date posted
2019 Year 11 Month 13 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics 
Subjective syndrome of paresthesia on the leg.
Participant flow 
No problem
Adverse events 
Nothing particular
Outcome measures 
Not finalized
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Terminated
Date of protocol fixation
2011 Year 11 Month 01 Day
Date of IRB
2011 Year 11 Month 01 Day
Anticipated trial start date
2011 Year 11 Month 01 Day
Last follow-up date
2016 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information IRB approval waiting

Management information
Registered date
2011 Year 11 Month 01 Day
Last modified on
2019 Year 11 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000007752