UMIN-CTR Clinical Trial

Basic information
Public title	Clinical trial to evaluate efficacy and safety of apheresis therapy on peripheral arterial disease with critical limb ischemia.
Acronym	Clinical trial of apheresis therapy on peripheral arterial disease (ASK-005).
Scientific Title	Clinical trial to evaluate efficacy and safety of apheresis therapy on peripheral arterial disease with critical limb ischemia.
Scientific Title:Acronym	Clinical trial of apheresis therapy on peripheral arterial disease (ASK-005).
Region	Japan

Condition
Condition	Peripheral arterial disease
Classification by specialty	Cardiology Nephrology Clinical immunology Vascular surgery Dermatology Radiology Cardiovascular surgery Plastic surgery
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the efficacy to heal ischemic ulcer and the safety of apheresis therapy in patients with peripheral arterial disease
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase	Phase III

Assessment
Primary outcomes	Rate of completely healed ischemic ulcer upon to 24 weeks after apheresis therapy
Key secondary outcomes	1. Time to complete ischemic ulcer healing 2. Granulation formation in ischemic ulcer 3. Changes in skin perfusion pressure at the foot with ischemic ulcer 4. Changes in ankle brachial index 5. Analysis of adverse events

Base
Study type	Interventional

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

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	Apheresis therapy Single treatment is up to 2 hours. Twice a week, up to 24 treatments (for 12 weeks).
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	85 years-old >=
Gender	Male and Female
Key inclusion criteria	1. Patients 20 to 85 years of age 2. Patients above 45 kg body weight 3. Patients with ischemic ulcer below lisfranc joint 4. Patients with SPP 20 to 50 mmHg at dorsal or planter of foot with ischemic ulcer 5. Patients who are no option for revascularization as determined by an independent third party vascular specialist
Key exclusion criteria	1. Patients below SPP 20 mmHg at dorsal or planter of foot with ischemic ulcer 2. Patients with ischemic ulcer above ankle joint 3. Patients with metatarsal osteomyelitis 4. Patients planned to undergo major amputation of any lower limb above lisfranc joint 5. Patients who are unable to refrain from angiotensin converting enzyme inhibitor
Target sample size	61

Research contact person
Name of lead principal investigator	1st name Shuzo Middle name Last name Kobayashi
Organization	Shonan Kamakura General Hospital
Division name	Kidney Disease and Transplant Center
Zip code	247-8533
Address	1370-1, Okamoto, Kamakura, Kanagawa, 247-8533 Japan
TEL	080-2408-0766
Email	Masaji.Kawatsu@kaneka.co.jp

Public contact
Name of contact person	1st name Masaji Middle name Last name Kawatsu
Organization	Kaneka Corporation
Division name	Medical Devices Solutions Vehicle
Zip code	107-6028
Address	1-12-32, Akasaka, Minato-ku, Tokyo, 107-6028 Japan
TEL	080-2408-0766
Homepage URL
Email	Masaji.Kawatsu@kaneka.co.jp

Sponsor
Institute	Kaneka Corporation
Institute
Department

Funding Source
Organization	Kaneka Corporation
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Mirai Iryo Research Center Inc.
Address	1-8-7, Koji-machi, Chiyoda-ku, Tokyo 102-0083, Japan
Tel	080-2408-0766
Email	Masaji.Kawatsu@kaneka.co.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	2015 Year 12 Month 25 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	61
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	Completed
Date of protocol fixation	2015 Year 04 Month 07 Day
Date of IRB	2015 Year 06 Month 30 Day
Anticipated trial start date	2015 Year 08 Month 27 Day
Last follow-up date	2019 Year 07 Month 08 Day
Date of closure to data entry	2019 Year 09 Month 30 Day
Date trial data considered complete	2019 Year 11 Month 30 Day
Date analysis concluded	2020 Year 01 Month 31 Day

Other
Other related information

Management information
Registered date	2015 Year 12 Month 25 Day
Last modified on	2020 Year 01 Month 07 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000023462