UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038282 |
|---|---|
| Receipt number | R000043618 |
| Scientific Title | Multi-institutional clinical study to verify the efficacy and safety of wearing custom-made compression elastic garment in cases of Klippel-Trenaunay syndrome |
| Date of disclosure of the study information | 2019/10/12 |
| Last modified on | 2020/10/14 10:01:09 |
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Basic information
Public title
Multi-institutional clinical study to verify the efficacy and safety of wearing custom-made compression elastic garment in cases of Klippel-Trenaunay syndrome
Acronym
Custom-made compression elastic garment in Klippel-Trenaunay syndrome
Scientific Title
Multi-institutional clinical study to verify the efficacy and safety of wearing custom-made compression elastic garment in cases of Klippel-Trenaunay syndrome
Scientific Title:Acronym
Custom-made compression elastic garment in Klippel-Trenaunay syndrome
Region
| Japan |
Condition
Condition
Vascular malformation
Klippel-Trenaunay syndrome
Classification by specialty
| Pediatrics | Radiology | Plastic surgery |
| Adult | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Verifying the efficacy and safety of wearing custom-made compression elastic garment in cases of Klippel-Trenaunay syndrome
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Lower limb circumferences on the affected side
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
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Wearing custom-made garments
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
| 2 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients as Klippel-Trenaunay syndrome
Over 2 years of age
Patients having the lesion on the calf
Patients who can walk independently
Key exclusion criteria
Patients who received surgical interventions including sclerotherapy within 12 weeks
Patients who have allergy against the garment materials
Patients who must keep taking diuretic agents
Patients who suffered from heart failure within one year
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Shunsuke |
| Middle name | |
| Last name | Yuzuriha |
Organization
Shinshu University School of Medicine
Division name
Department of Plastic and Reconstructive Surgery
Zip code
390-8621
Address
3-1-1 Asahi, Matsumoto, Nagano-prefecture
TEL
0263-37-2833
yuzuriha@shinshu-u.ac.jp
Public contact
Name of contact person
| 1st name | Shunsuke |
| Middle name | |
| Last name | Yuzuriha |
Organization
Shinshu University School of Medicine
Division name
Department of Plastic and Reconstructive Surgery
Zip code
390-8621
Address
3-1-1 Asahi, Matsumoto, Nagano-prefecture
TEL
0263-37-2833
Homepage URL
yuzuriha@shinshu-u.ac.jp
Sponsor or person
Institute
Shinshu University
Institute
Department
Personal name
Funding Source
Organization
Political research project for intractable diseases, Ministry of Health, Labor and Welfare in Japan
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Shinshu University School of Medicine
Address
3-1-1 Asahi, Matsumoto, Nagano-prefecture
Tel
0263-37-2572
mdrinri@shinshu-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
信州大学医学部附属病院形成外科（長野県）、国家公務員共済組合連合会斗南病院形成外科（北海道）、福岡大学病院形成外科（福岡県）、神戸大学医学部附属病院形成外科（兵庫県）、大阪医科大学病院附属病院放射線科（大阪府）
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 10 | Month | 12 | 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
Completed
Date of protocol fixation
| 2019 | Year | 10 | Month | 10 | Day |
Date of IRB
| 2019 | Year | 10 | Month | 10 | Day |
Anticipated trial start date
| 2019 | Year | 10 | Month | 15 | Day |
Last follow-up date
| 2020 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
| 2020 | Year | 06 | Month | 26 | Day |
Date analysis concluded
| 2020 | Year | 09 | Month | 11 | Day |
Other
Other related information
Management information
Registered date
| 2019 | Year | 10 | Month | 12 | Day |
Last modified on
| 2020 | Year | 10 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043618
| Research Plan | |
|---|---|
| Registered date | File name |
| 2020/04/13 | 20200301 修正版（承認日入） KTSストッキング 介入研究プロトコール.docx |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
