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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000028226
Receipt No. R000032306
Scientific Title Consideration of severity classification in limb lymphoedema patients based on lymph function
Date of disclosure of the study information 2019/04/01
Last modified on 2018/01/14

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Basic information
Public title Consideration of severity classification in limb lymphoedema patients based on lymph function
Acronym Consideration of severity classification in limb lymphoedema patients based on lymph function
Scientific Title Consideration of severity classification in limb lymphoedema patients based on lymph function
Scientific Title:Acronym Consideration of severity classification in limb lymphoedema patients based on lymph function
Region
Japan

Condition
Condition chronic lymphedema
Classification by specialty
Plastic surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Extremity lymphoedema is classified as stages based on physical assessment such as limb circumference measurement, skin tone, frequency of hypothyroiditis, but these evaluation methods do not reflect lymphatic function. In this study, lymphoscintigraphy (SPECT / CT) and fluorescence lymphangiography with ICG are used to evaluate lymphatic function in limb lymphoedema patients, from that viewpoint classification and severity classification of limb lymphedema It aims. Other factors, skin hardness measured by patient factors and hardness measuring instruments, conservative therapy, and surgical therapy will also be studied and will help to prepare therapeutic guidelines for limb lymphedema.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Severity classification of chronic lymphoedema using lymphoscintigraphy and ICG fluorescence lymphangiography
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 Diagnosis
Type of intervention
Medicine Device,equipment
Interventions/Control_1 Lymphoscintigraphy, ICG fluorescence lymphangiography etc.
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
1 years-old <=
Age-upper limit
80 years-old >
Gender Male and Female
Key inclusion criteria (1) Patients whose age at registration is from 1 to 80 years, patients without gender (2) Patients diagnosed with limb lymphoedema (3) Presence or absence of previous treatment history is not required (4) Patients whose SBP is less than 160 mm Hg and diastolic blood pressure is less than 100 mm Hg (5) Patients who can walk freely (6) Patients for whom consent is documented for participation in this study
Key exclusion criteria (1) diabetic patients uncontrollable by medication (fasting blood glucose level 130 mg / dL or more)
(2) Patients who are pregnant, may be pregnant, or prefer pregnancy during treatment
(3) Other patients judged inappropriate for judgment by doctor's judgment
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Maegawa Jiro
Organization Yokohama City University
Division name School of Medicine, Department of Plastic and Reconstructive Surgery
Zip code
Address Fukuura 3-9, Kanazawa-ku, Yokohama City, Kanagawa Prefecture
TEL 045-787-2709
Email prs_ycu@yokohama-cu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yabuki Yuichiro
Organization Yokohama City University
Division name School of Medicine, Department of Plastic and Reconstructive Surgery
Zip code
Address Fukuura 3-9, Kanazawa-ku, Yokohama City, Kanagawa Prefecture
TEL 045-787-2709
Homepage URL
Email yu1rou@yokohama-cu.ac.jp

Sponsor
Institute Yokohama City University
Institute
Department

Funding Source
Organization nothing
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
Email

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
2019 Year 04 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
2015 Year 11 Month 16 Day
Date of IRB
Anticipated trial start date
2015 Year 11 Month 16 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
2017 Year 07 Month 13 Day
Last modified on
2018 Year 01 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032306

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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