UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020336 |
|---|---|
| Receipt number | R000023462 |
| Scientific Title | Clinical trial to evaluate efficacy and safety of apheresis therapy on peripheral arterial disease with critical limb ischemia. |
| Date of disclosure of the study information | 2015/12/25 |
| Last modified on | 2020/01/07 17:58:00 |
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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
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
Masaji.Kawatsu@kaneka.co.jp
Sponsor or person
Institute
Kaneka Corporation
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023462
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