UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Combination of revascularization surgery and double filtration plasmapheresis with thermo-recirculation (DF Thermo) for the treatment of peripheral arterial disease (ASO)
Title of the study (Brief title)	Combination of revascularization surgery and double filtration plasmapheresis with thermo-recirculation (DF Thermo) for the treatment of peripheral arterial disease (ASO)
Region	Japan

Condition
Condition	Peripheral arterial disease with wound and/or ulcer in the lower limb
Classification by specialty	Plastic surgery
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the efficacy of DF Thermo therapy in the severe ischemic limb ASO patients who underwent bypass revascularization surgery, and with wound and/or ulcer in the lower limb.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Rate of diminishment of wound and/or ulcer by DF thermo therapy
Key secondary outcomes	SPP, ABI, ultrasonography of lower limb, VEGF, fibrinogen, IgM, LDL-cholesterol, HDL-cholesterol, total cholesterol, DESIGN-R, Vascu QOL

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	DF Thermo group (Patients underwent DF Thermo therapy) Study period; 35 weeks at the maximum
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	86 years-old >
Gender	Male and Female
Key inclusion criteria	Patients who fulfill all of the following conditions are included. 1) Age is over 20 years and less than 86 years, regardless of sex 2) Diagnosed as ASO with Fontaine Grade IV 3) With wound and/or ulcer in the lower limb and underwent bypass revascularization surgery 4) Patients who can give written informed consent by themselves or by their surrogates, understanding the objective and content of the study
Key exclusion criteria	Patients who fulfill any of the following conditions are excluded. 1) Pregnancy, breast-feeding, with possibility of pregnancy, or who wish to become pregnant during the study period 2) Patients who are considered as inadequate by the physician in charge
Target sample size	12

Research contact person
Name of lead principal investigator	Shinji Togashi
Organization	Shonai Amarume Hospital
Division name	Plastic and reconstructive surgery
Address	1-1-1 Shoyo, Shonai-town, Hogashitagawa, Yamagata
TEL	0234-43-3434
Email	stoga@amarume-hp.jp

Public contact
Name of contact person	Shinji Togashi
Organization	Shonai Amarume Hospital
Division name	Plastic and reconstructive surgery
Address	1-1-1 Shoyo, Shonai-town, Hogashitagawa, Yamagata
TEL	0234-43-3434
Homepage URL
Email	stoga@amarume-hp.jp

Sponsor
Institute	Shonai Amarume Hospital
Institute
Department

Funding Source
Organization	Kawasumi Laboratories, Inc.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

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

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	2015 Year 02 Month 20 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2015 Year 01 Month 05 Day
Anticipated trial start date	2015 Year 02 Month 25 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2015 Year 02 Month 19 Day
Last modified on	2017 Year 12 Month 23 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000019240