UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000059826 |
|---|---|
| Receipt number | R000067295 |
| Scientific Title | Evaluation of subcutaneous fat fibrosis in patients with lymphedema using ultrasonography |
| Date of disclosure of the study information | 2025/11/20 |
| Last modified on | 2025/11/19 15:36:46 |
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Basic information
Public title
Evaluation of subcutaneous fat fibrosis in patients with lymphedema using ultrasonography
Acronym
Evaluation of subcutaneous fat fibrosis in patients with lymphedema
Scientific Title
Evaluation of subcutaneous fat fibrosis in patients with lymphedema using ultrasonography
Scientific Title:Acronym
Evaluation of subcutaneous fat fibrosis in patients with lymphedema
Region
| Japan |
Condition
Condition
lymphedema
Classification by specialty
| Plastic surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Lymphedema is progressive once it develops, and in advanced cases, it becomes intractable with marked fibrosis of subcutaneous fat, significantly impairing the patient's quality of life. However, there are currently no tests available to evaluate fat fibrosis. We aim to establish a method for evaluating fat tissue fibrosis using ultrasound.
Basic objectives2
Others
Basic objectives -Others
To compare ultrasonography findings of subcutaneous adipose tissue with histological findings of adipose tissue obtained by surgery.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Ultrasound findings of the subcutaneous fat layer
Histological findings of fibrosis in the subcutaneous fat tissue
Key secondary outcomes
Histological findings of fibrosis in lymphatic vessels
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
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
The patient with upper or lower limb lymphedema who has consented to participate in the study and is undergoing lymphatic venous anastomosis.
The patient who is undergoing reconstructive surgery using a anterolateral thigh flap or fascia lata graft and has consented to participate in the study.
Key exclusion criteria
No
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Takashi |
| Middle name | |
| Last name | Nuri |
Organization
Osaka Medical and Pharmaceutical University
Division name
Plastic Surgery
Zip code
569-8686
Address
2-7 Daigaku-cho, Takatsuki-shi, Osaka, Japan
TEL
072-683-1221
trad@ompu.ac.jp
Public contact
Name of contact person
| 1st name | Yuri |
| Middle name | |
| Last name | Yae |
Organization
Osaka Medical and Pharmaceutical University
Division name
Plastic Surgery
Zip code
569-8686
Address
2-7 Daigaku-cho, Takatsuki-shi, Osaka, Japan
TEL
072-683-1221
Homepage URL
yuri.yae@ompu.ac.jp
Sponsor or person
Institute
Osaka Medical and Pharmaceutical University
Institute
Department
Personal name
Funding Source
Organization
Osaka Medical and Pharmaceutical University
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Osaka Medical and Pharmaceutical University
Address
2-7 Daigaku-cho, Takatsuki-shi, Osaka, Japan
Tel
072-683-1221
trad@ompu.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
| 2025 | Year | 11 | Month | 20 | 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
| 2025 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2025 | Year | 07 | Month | 22 | Day |
Anticipated trial start date
| 2025 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Observational study
Study period: April 1, 2025-March 31, 2028
Participants: Patients undergoing LVA for upper or lower limb lymphedema
Management information
Registered date
| 2025 | Year | 11 | Month | 19 | Day |
Last modified on
| 2025 | Year | 11 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000067295
