臨床研究等提出・公開システム

Japanese

Date of registration	Nov. 18, 2021
Last modified on	Oct. 25, 2023
Trial ID	jRCTs021210047

Scientific Title	Treatment of refractory skin ulcers with Simonkolleite
Public Title	Treatment of refractory ulcers with Simonkolleite

Contact for Scientific Queries	Name	Norio Fukuda
	Affiliation	Yamagata University Hospital
	Address	2-2-2 iidanishi yamagatashi yamagataken 990-0585
	Telephone	+81-23-628-5413
	E-mail	n-fukuda@med.id.yamagata-u.ac.jp
Contact for Public Queries	Name	Norio Fukuda
	Affiliation	Yamagata University Hospital
	Address	2-2-2 iidanishi yamagatashi yamagataken 990-0585
	Telephone	+81-23-628-5413
	E-mail	n-fukuda@med.id.yamagata-u.ac.jp

Recruitment status	Recruiting

Anticipated date of first enrollment		Nov. 18, 2021
Actual date of first enrollment
Target sample size		10
Study Type		Interventional
Study Design	allocation	single arm study
	masking	open(masking not used)
	control	uncontrolled control
	assignment	single assignment
	purpose	treatment purpose
Key inclusion & exclusion criteria	Inclusion Criteria	1. Patients who do not show a healing tendency after 3 weeks or more of existing conservative treatments [ointment treatment, wound dressing, basic fibroblast growth factor (bFGF), continuous negative pressure wound therapy (NPWT) etc.] 2. Patients who explained the purpose of this study in a separate document and obtained written consent
	Exclusion Criteria	1. Patients with ulcer infection 2. Patients with refractory skin ulcers caused by artificial objects 3. Patients with refractory skin ulcers caused by malignant tumors 4. Patients being treated for malignant tumors 5. Pregnant patients 6. Other patients deemed inappropriate by researchers
	Age Minimum	20age old over
	Age Maximum	65age old under
	Gender	Both
Health Condition(s) or Problem(s) Studied		refractory skin ulcer
Intervention(s)		After thoroughly washing and cleaning the skin ulcer surface of the target patient with physiological saline, 6.4 mg of sterilized simoncolite powder per 1 cm2 of ulcer is evenly sprinkled. After spraying, apply sanitary material according to the amount of exudate as top dressing. A medical examination is performed every 2-4 days, and the ulcer and surrounding skin are observed. If there is no contamination at the time of observation, do not replace the dressing (or replace only the upper sanitary material), fix it again, and if the wound surface is contaminated, clean the wound and remove Simoncolite powder. Sprinkle the same amount again and coat with new sanitary material. Continue this for 3 weeks.
Health Condition(s) Keyword		skin ulcer
Intervention(s) Keyword		Simonkolleite
Health Condition(s) Code
Intervention(s) Code
Primary Outcome(s)		Detection of adverse findings
Secondary Outcome(s)		Reduction rate of ulcer area and volume

Primary Sponsor

Source of Monetary Support / Secondary Sponsor	JFE MINERAL Co, LTD.
Secondary Sponsor	Applicable

Source of Monetary Support
Secondary Sponsor

Name of Certified Review Board	Tohoku Certified Review Board of Tohoku University
Address	2-1-1 Katahira, Aoba-ku, Sendai, Miyagi, 980-8577 Japan, Miyagi
Telephone	+81-22-718-0461
E-Mail	office@nrs.hosp.tohoku.ac.jp
Approval Status	Approval
Date of approval	Sept. 15, 2021

Plan to share IPD	No
Plan description

Secondary ID(s)
Issuing Authority

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
6	Oct. 25, 2023	(this page)	Changes
5	Oct. 24, 2023	Detail	Changes
4	June. 06, 2022	Detail	Changes
3	May. 30, 2022	Detail	Changes
2	May. 27, 2022	Detail	Changes
1	Nov. 18, 2021	Detail

List of change history