UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016584 |
|---|---|
| Receipt number | R000019240 |
| Scientific Title | Combination of revascularization surgery and double filtration plasmapheresis with thermo-recirculation (DF Thermo) for the treatment of peripheral arterial disease (ASO) |
| Date of disclosure of the study information | 2015/02/20 |
| Last modified on | 2017/12/23 15:23:11 |
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Basic information
Public title
Combination of revascularization surgery and double filtration plasmapheresis with thermo-recirculation (DF Thermo) for the treatment of peripheral arterial disease (ASO)
Acronym
Combination of revascularization surgery and double filtration plasmapheresis with thermo-recirculation (DF Thermo) for the treatment of peripheral arterial disease (ASO)
Scientific Title
Combination of revascularization surgery and double filtration plasmapheresis with thermo-recirculation (DF Thermo) for the treatment of peripheral arterial disease (ASO)
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Shinji Togashi |
Organization
Shonai Amarume Hospital
Division name
Plastic and reconstructive surgery
Zip code
Address
1-1-1 Shoyo, Shonai-town, Hogashitagawa, Yamagata
TEL
0234-43-3434
stoga@amarume-hp.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shinji Togashi |
Organization
Shonai Amarume Hospital
Division name
Plastic and reconstructive surgery
Zip code
Address
1-1-1 Shoyo, Shonai-town, Hogashitagawa, Yamagata
TEL
0234-43-3434
Homepage URL
stoga@amarume-hp.jp
Sponsor or person
Institute
Shonai Amarume Hospital
Institute
Department
Personal name
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)
IRB Contact (For public release)
Organization
Address
Tel
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 |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
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
Terminated
Date of protocol fixation
| 2015 | Year | 01 | Month | 05 | Day |
Date of IRB
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
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019240
