臨床研究等提出・公開システム

Scientific Title	Study on Therapeutic effects of granulocyte adsorption column (Adacolumn) for pyoderma gangrenosum (Therapeutic effects of granulocyte adsorption column)
Public Title	Study on Therapeutic effects of granulocyte adsorption column (Adacolumn) for pyoderma gangrenosum (Therapeutic effects of granulocyte adsorption column)

Completion date	Nov. 04, 2023
Result actual enrolment	35
Baseline Characteristics	Of the 35 cases performed, 15 were males and 20 were females, ranging in age from 21 to 81 years. All cases were treated with granulocyte and monocyte adsorption apheresis because of the single-open trial.
Participant flow	Of the 35 cases, 34 were completed and 1 was withdrawn.
Adverse events	No serious adverse events occurred.
Outcome measures	The primary endpoint of skin ulcer area reduction was 68.4%. Secondary endpoints were 3.1 +- 0.2 PGA before treatment and 2.1+- 0.2 after treatment. Pain VAS improved in all cases measured, regardless of effect. CRP was significantly reduced in the effective cases. Other counts such as white blood cell count, neutrophil count, monocyte count, and platelet count did not differ between pre- and post-treatment.
Brief summary	Granulocyte and monocyte adsorption apheresis was performed for refractory skin ulcers in pyoderma gangrenosum. The achievement rate of skin ulcer area reduction was 68.4%. No serious adverse events occurred.
Date of posting of results summaries	Mar. 31, 2024
Date of the first journal publication of results	Aug. 09, 2021
URL hyperlink(s) related to results and publications	https://pubmed.ncbi.nlm.nih.gov/34369050/

Plan to share IPD	No
Plan description	Not applicable
URL link to protocol file(s) with version and date	https://jrct.mhlw.go.jp/latest-detail/jRCTs072180053

Contact for Scientific Queries	Name	Higashi Yuko
	Affiliation	Kagoshima University Hospital
	Address	8-35-1 Sakuragaoka Kagoshima City, Kagoshima
	Telephone	+81-99-275-5388
	E-mail	higashiy@m.kufm.kagoshima-u.ac.jp
Contact for Public Queries	Name	Higashi Yuko
	Affiliation	Kagoshima University Hospital
	Address	8-35-1 Sakuragaoka, Kagoshima City, Kagoshima
	Telephone	+81-99-275-5388
	E-mail	higashiy@m.kufm.kagoshima-u.ac.jp

Recruitment status	Complete

Anticipated date of first enrollment		July. 31, 2015
Actual date of first enrollment		Nov. 09, 2015
Target sample size		65
Study Type		Interventional
Study Design	allocation	single arm study
	masking	open(masking not used)
	control	no treatment control/standard of care control
	assignment	single assignment
	purpose	treatment purpose
Key inclusion & exclusion criteria	Inclusion Criteria	Pyoderma gangrenosum
	Exclusion Criteria	Severe infection
	Age Minimum	20age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		Pyoderma gangrenosum
Intervention(s)		Therapy of granulocyte adsorption column
Health Condition(s) Keyword		Pyoderma gangrenosum
Health Condition(s) Code		L88
Primary Outcome(s)		Reduction rate of skin ulcer area
Secondary Outcome(s)		Visual Analogue Scale, physician's global assessment

Name of Certified Review Board	Kagoshima University Clinical Research Review Board
Address	1-21-24, Korimoto Kagoshima city, Kagoshima, Kagoshima
Telephone	+81-99-275-6624
E-Mail	crmc@m2.kufm.kagoshima-u.ac.jp
Approval Status	Approval
Date of approval	Mar. 13, 2019

Countries of Recruitment（Except Japan）	none

History of Changes

List of change history