UMIN-CTR Clinical Trial

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

small fiber neuropathy

Classification by specialty

Neurology

Dermatology

Classification by malignancy

Others

Genomic information

NO

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

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

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Department of Dermatology
Saitama Medical Center, Saitama Medical University

Institute

Department

Personal name

Organization

Department of Dermatology
Saitama Medical Center, Saitama Medical University

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Japan

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

埼玉医科大学総合医療センター (埼玉県)

Date of disclosure of the study information

2011

Year

11

Month

01

Day

URL releasing protocol

Unpublished

Publication of results

Unpublished

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

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 related information

IRB approval waiting

Registered date

2011

Year

11

Month

01

Day

Last modified on

2019

Year

11

Month

13

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007752