臨床研究等提出・公開システム

Japanese

Date of registration	Sept. 05, 2021
Last modified on	Sept. 05, 2021
Trial ID	jRCT1052210078

Scientific Title	Clinical study on physiological indicators of pain in patients with foot ulcers
Public Title	Clinical study on physiological indicators of pain in patients with foot ulcers

Contact for Scientific Queries	Name	Kunihiro Nakai
	Affiliation	University of Fukui Hospital
	Address	23-3,Matsuokashimoaizuki,Eiheiji-cho,Yoshida-gun,Fukui
	Telephone	+81-776-61-8861
	E-mail	knakai@u-fukui.ac.jp
Contact for Public Queries	Name	Kunihiro Nakai
	Affiliation	University of Fukui Hospital
	Address	23-3,Matsuokashimoaizuki,Eiheiji-cho,Yoshida-gun,Fukui
	Telephone	+81-776-61-8861
	E-mail	knakai@u-fukui.ac.jp

Recruitment status	Recruiting

Anticipated date of first enrollment		Sept. 05, 2021
Actual date of first enrollment
Target sample size		60
Study Type		Interventional
Study Design	allocation	single arm study
	masking	open(masking not used)
	control	uncontrolled control
	assignment	single assignment
	purpose	diagnostic purpose
Key inclusion & exclusion criteria	Inclusion Criteria	1.Patients who were diagnosed with foot ulcer 2.Age: patients over 20 at the time of acquiring consent 3.Gender: male and female 4.Patients who have consented to particpate in this study after receiving sufficient explanation for this study and gained sufficient understandings
	Exclusion Criteria	A patient who was judged as inappropriate as a research subject by the research director
	Age Minimum	20age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		Foot ulcer
Intervention(s)		Thrmal stimulation The experimental thermal stimuli of 30 degrees to 50 degrees are applied to the forearm of the research subject using the thermal stimulator. Ischemic condition The ischemic condition is induced by the exercise such as bending and stretching of the fingers or ankle of the research subject, with the bag-shaped belt for blood pressure measurement wrapped and inflated around the upper arm or thigh.
Health Condition(s) Keyword		Foot ulcer, Crinical limb ischemia, Pain
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome(s)		Electroencephalogram-based pain scores, Numerical Rating Scale, Visual Analogue Scale, Current value from Pain Vision Value of SFMPQ-2
Secondary Outcome(s)		Pulse rate, Pulse wave amplitude, Skin conductance response

Primary Sponsor

Source of Monetary Support / Secondary Sponsor
Secondary Sponsor

Source of Monetary Support	PaMeLa Inc.
Secondary Sponsor	Applicable

Name of Certified Review Board	The Research Ethics Committee of University of Fukui
Address	23-3,Matsuokashimoaizuki,Eiheiji-cho,Yoshida-gun, Fukui
Telephone	+81-776-61-8640
E-Mail	rinrisys@ml.u-fukui.ac.jp
Approval Status	Approval
Date of approval	Mar. 09, 2021

Plan to share IPD	No
Plan description

Secondary ID(s)
Issuing Authority

Countries of Recruitment（Except Japan）	none