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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000040058
Receipt No. R000045672
Scientific Title Involvement of Senescence cell in Diabetic hand syndrome
Date of disclosure of the study information 2020/06/01
Last modified on 2021/05/06

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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
Institute Nagoya University, Department of Hand Surgery
Institute
Department

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
2023 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
2021 Year 05 Month 06 Day


Link to view the page
URL(English) https://upload.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


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