UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Extension of collagenase injection into the pretendinous cord in patients with Dupuytren contracture
Title of the study (Brief title)	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

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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	Shigeharu Uchiyama
Organization	Department of Orthopaedic Surgery Shinshu University School of Medicine
Division name	Orthopaedic Surgery
Address	Asahi3-1-1 Matsumoto JAPAN
TEL	0263-37-3095
Email	sigeuti@shinshu-u.ac.jp

Public contact
Name of contact person	Shigeharu Uchiyama
Organization	Department of Orthopaedic Surgery Shinshu University School of Medicine
Division name	Orthopaedic Surgery
Address	Asahi3-1-1 Matsumoto JAPAN
TEL	0263-37-3095
Homepage URL
Email	sigeuti@shinshu-u.ac.jp

Sponsor
Institute	Department of Orthopaedic Surgery Shinshu University School of Medicine
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

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)

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

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2016 Year 07 Month 04 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026625