UMIN-CTR Clinical Trial

Basic information
Public title	Effects of local cooling on skin blood flow response in persons with spinal cord injuries
Acronym	Cold-induced cutaneous vasodilation in SCI
Scientific Title	Effects of local cooling on skin blood flow response in persons with spinal cord injuries
Scientific Title:Acronym	Cold-induced cutaneous vasodilation in SCI
Region	Japan

Condition
Condition	Cervical, thoracic, and lumbar spinal cord injuries
Classification by specialty	Rehabilitation medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The aim of this study is to assess whether cold-induced cutaneous vasodilation, which is observed during cold water immersion of fingertips in able-bodies, occur even in a non-sensate area for spinal cord injuries and what temperature and how many minutes will need to induce the response.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	A number of participants who will get a cold-induced cutaneous vasodilation (CIVD).
Key secondary outcomes	A delay, time constant, and maximal amplitude of a CIVD curve

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	YES
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Prevention
Type of intervention	Maneuver
Interventions/Control_1	Local cooling at 15 and 8 degrees for 15 min of each
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	65 years-old >
Gender	Male and Female
Key inclusion criteria	Persons with spinal cord injuries C5-L2. AIS A Persons who can communicate Persons who wish to participate the present study voluntarily Persons without diabetes mellitus, hypertension, abnormal lipid metabolism Persons who have been injured for more than 6 months
Key exclusion criteria	Persons affected by the followings: inflammatory cutaneous disease infection at the measurement arteriosclerosis obliterans collargen disease liver disease skin atrophy aging over 65 y.o. receiving steroid treatment
Target sample size	16

Research contact person
Name of lead principal investigator	1st name Yoshi-ichiro Middle name Last name Kamijo
Organization	Wakayama Medical University
Division name	Department of Rehabilitaion Medicine
Zip code	641-8509
Address	811-1 Kimidera
TEL	0734410664
Email	yoshikmj@wakayama-med.ac.jp

Public contact
Name of contact person	1st name Yoshi-ichiro Middle name Last name Kamijo
Organization	Wakayama Medical University
Division name	Department of Rehabilitaion Medicine
Zip code	641-8509
Address	811-1 Kimidera
TEL	0734410664
Homepage URL
Email	yoshikmj@wakayama-med.ac.jp

Sponsor
Institute	Department of Rehabilitaion Medicine, Wakayama Medical University
Institute
Department

Funding Source
Organization	Department of Rehabilitaion Medicine, Wakayama Medical University
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Research Ethics Committee of Wakayama Medical University
Address	811-1 Kimiidera, Wakayama 641-8509, Japan
Tel	073-447-2300 ext.3692, 3693
Email	wa-rinri@wakayama-med.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	2022 Year 01 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	Preinitiation
Date of protocol fixation	2020 Year 03 Month 30 Day
Date of IRB
Anticipated trial start date	2020 Year 06 Month 01 Day
Last follow-up date	2025 Year 03 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2020 Year 05 Month 08 Day
Last modified on	2020 Year 05 Month 08 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046015