UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021401 |
|---|---|
| Receipt number | R000024682 |
| Scientific Title | Change of edema and transcutaneous oxygen tension in the lower extremities of the patients with sports-related soft tissue injury during hyperbaric oxygen therapy |
| Date of disclosure of the study information | 2016/03/08 |
| Last modified on | 2024/03/14 09:09:10 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Change of edema and transcutaneous oxygen tension in the lower extremities of the patients with sports-related soft tissue injury during hyperbaric oxygen therapy
Acronym
Change of edema and tcPO2 in the lower extremities of the patients with sports-related soft tissue injury during HBO2
Scientific Title
Change of edema and transcutaneous oxygen tension in the lower extremities of the patients with sports-related soft tissue injury during hyperbaric oxygen therapy
Scientific Title:Acronym
Change of edema and tcPO2 in the lower extremities of the patients with sports-related soft tissue injury during HBO2
Region
| Japan |
Condition
Condition
sports-related soft tissue injury in the lower extremities
Classification by specialty
| Orthopedics | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To establish efficient HBO2 protocol according to understandings between edema and transcutaneous oxygen tension in the lower extremities of the patients with sports-related soft tissue injury
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Measure and analyze transcutaneous oxygen tension in the lower extremities during HBO2 at early and chronic phase after injury
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
Prevention
Type of intervention
| Other |
Interventions/Control_1
measurement of transcutaneous oxygen tension (tcpO2) on limbs of patients with sports related soft tissue injury
pre, during, post hyperbaric oxygen therapy (2 hours)
two time points at acute and chronic phase within 10 days after injury
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
| 40 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients with sports-related soft tissue injury in the lower extremity
Key exclusion criteria
1. patients with no consent
<HBO contra-indication>
patients with
1)impossible for equalizing pressure of the
ear
2)claustrophobia
3)possibility of pregnancy
4)congenital pulmonary cystic diseases, and
past history of pneumothorax
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Kazuyoshi |
| Middle name | |
| Last name | Yagishita |
Organization
Medical Hospital of Tokyo Medical and Dental
University
Division name
Hyperbaric Medical Center/ Sports Medicine Clinical Center
Zip code
1138519
Address
1-5-45, Yushima, Bunkyo-ku, Tokyo, Japan
TEL
0358035341
yagishita.orth@tmd.ac.jp
Public contact
Name of contact person
| 1st name | Kazuyoshi |
| Middle name | |
| Last name | Yagishita |
Organization
Medical Hospital of Tokyo Medical and Dental University
Division name
Hyperbaric Medical Center/ Sports Medicine Clinical Center
Zip code
1138519
Address
1-5-45, Yushima, Bunkyo-ku, Tokyo, Japan
TEL
0358035341
Homepage URL
yagishita.orth@tmd.ac.jp
Sponsor or person
Institute
Tokyo Medical and Dental University Faculty
of Medicine
Institute
Department
Personal name
Funding Source
Organization
Tokyo Medical and Dental University Faculty
of Medicine
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
Tokyo Medical and Dental University
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo
Tel
03-5803-5096
kenkyo.adm@cmn.tmd.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
| 2016 | Year | 03 | Month | 08 | 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
| 2015 | Year | 01 | Month | 05 | Day |
Date of IRB
| 2015 | Year | 01 | Month | 05 | Day |
Anticipated trial start date
| 2015 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 03 | Month | 08 | Day |
Last modified on
| 2024 | Year | 03 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024682
