UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023119 |
|---|---|
| Receipt number | R000026625 |
| Scientific Title | Extension of collagenase injection into the pretendinous cord in patients with Dupuytren contracture |
| Date of disclosure of the study information | 2016/07/11 |
| Last modified on | 2016/07/11 21:49:29 |
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Basic information
Public title
Extension of collagenase injection into the pretendinous cord in patients with Dupuytren contracture
Acronym
Dupuytren
Scientific Title
Extension of collagenase injection into the pretendinous cord in patients with Dupuytren contracture
Scientific Title:Acronym
Dupuytren
Region
| Japan |
Condition
Condition
Dupuytren
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Purpose of this study is to investigate how far collagenase extends beyond the pretendinous cord after injection, so that we could detect risk of flexor tendon rupture.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Extension of T2 high lesion in the involved hand right after collagenase injection
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Medicine |
Interventions/Control_1
MRI right after collagenase injection
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Dupytren contracture patients with pretendinous cord
Key exclusion criteria
Patients with history of allergic reaction to collagenase
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shigeharu Uchiyama |
Organization
Department of Orthopaedic Surgery
Shinshu University School of Medicine
Division name
Orthopaedic Surgery
Zip code
Address
Asahi3-1-1 Matsumoto JAPAN
TEL
0263-37-3095
sigeuti@shinshu-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shigeharu Uchiyama |
Organization
Department of Orthopaedic Surgery Shinshu University School of Medicine
Division name
Orthopaedic Surgery
Zip code
Address
Asahi3-1-1 Matsumoto JAPAN
TEL
0263-37-3095
Homepage URL
sigeuti@shinshu-u.ac.jp
Sponsor or person
Institute
Department of Orthopaedic Surgery Shinshu University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Shinshu University
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
Address
Tel
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
| 2016 | Year | 07 | Month | 11 | 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
Open public recruiting
Date of protocol fixation
| 2016 | Year | 07 | Month | 04 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 07 | Month | 11 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 07 | Month | 11 | Day |
Last modified on
| 2016 | Year | 07 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026625
