UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000040058
Receipt number R000045672
Scientific Title Involvement of Senescence cell in Diabetic hand syndrome
Date of disclosure of the study information 2020/06/01
Last modified on 2023/10/07 19:26:16

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Basic information

Public title

Study on the involvement of Senescence cell in Diabetic hand syndrome

Acronym

Senescence cell in Diabetic hand syndrome

Scientific Title

Involvement of Senescence cell in Diabetic hand syndrome

Scientific Title:Acronym

Senescence cell in Diabetic hand syndrome

Region

Japan


Condition

Condition

carpal tunnel syndrome, trigger finger, Dupuytren contracture

Classification by specialty

Orthopedics

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

to confirm that the Diabetic hand syndrome is histologically involved in hand aging.

Basic objectives2

Others

Basic objectives -Others

To find a regression function that predicts senescence-positive cells from the patient's background and hand function evaluation score as secondary outcomes

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Positive rate of senescent cells in tendon synovium, carpal tunnel syndrome, tendon sheath of trogger finger, contracture cord of Dupuytren's contracture.

Key secondary outcomes



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

20 years-old <=

Age-upper limit

100 years-old >=

Gender

Male and Female

Key inclusion criteria

carpal tunnel syndrome, trigger finger, Dupuytren contracture

Key exclusion criteria

rheumatoid arthritis, pyogenic tendinitis

Target sample size

30


Research contact person

Name of lead principal investigator

1st name Michiro
Middle name
Last name Yamamoto

Organization

Nagoya University

Division name

Department of Hand Surgery

Zip code

466-8550

Address

65 Tsurumai-cho, Showa-ku, Nagoya, Japan

TEL

0527442957

Email

michi-ya@med.nagoya-u.ac.jp


Public contact

Name of contact person

1st name Michiro
Middle name
Last name Yamamoto

Organization

Nagoya University

Division name

Department of Hand Surgery

Zip code

466-8550

Address

65 Tsurumai-cho, Showa-ku, Nagoya, Japan

TEL

0527442957

Homepage URL


Email

michi-ya@med.nagoya-u.ac.jp


Sponsor or person

Institute

Nagoya University, Department of Hand Surgery

Institute

Department

Personal name



Funding Source

Organization

Nagoya University, Department of Hand Surgery

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Nagoya University

Address

65 Tsurumai-cho, Showa-ku

Tel

0527412111

Email

ethics@med.nagoya-u.ac.jp


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



Other administrative information

Date of disclosure of the study information

2020 Year 06 Month 01 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results


Results date posted


Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics


Participant flow


Adverse events


Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Enrolling by invitation

Date of protocol fixation

2020 Year 04 Month 02 Day

Date of IRB

2020 Year 04 Month 02 Day

Anticipated trial start date

2020 Year 06 Month 01 Day

Last follow-up date

2025 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

none


Management information

Registered date

2020 Year 04 Month 04 Day

Last modified on

2023 Year 10 Month 07 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045672


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name