UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029535 |
|---|---|
| Receipt number | R000033704 |
| Scientific Title | Wound-directed Angiosome RevasculaRIzation apprOach to patients with cRitical limb iSchemia -Prospective multicenter observational study- |
| Date of disclosure of the study information | 2017/10/13 |
| Last modified on | 2024/07/29 14:49:38 |
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Basic information
Public title
Wound-directed Angiosome RevasculaRIzation apprOach to patients with cRitical limb iSchemia -Prospective multicenter observational study-
Acronym
WARRIORS
Scientific Title
Wound-directed Angiosome RevasculaRIzation apprOach to patients with cRitical limb iSchemia -Prospective multicenter observational study-
Scientific Title:Acronym
WARRIORS
Region
| Japan |
Condition
Condition
Patients with peripheral artery disease (PAD) associated with critical limbs ischemia (CLI)
Classification by specialty
| Cardiology | Endocrinology and Metabolism | Vascular surgery |
| Plastic surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the impact of angiosome concept on clinical outcomes after revascularization
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
12-month wound healing rate
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
a) Patients who can provide an informed consent and are aged 20 years or older when providing the consent
b) Patients had ischemic foot ulcer or gangrene with SPP<40 mmHg
c) Patient who evaluate ABI value before revascularization
d) Patient who receive infrapopliteal revascularization for limb salbage
Key exclusion criteria
a) Acute limb ischemia or critical limb ischemia due to non-atherosclerotic disease
b) CLI with unsalvageable tissue loss extended to beyond ankle
c) CLI with planed major amputation
Target sample size
450
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | 1)Osamu Iida, 2)Nobuyoshi Azuma |
Organization
1)Kansai Rosai Hospital, 2)Asahikawa Medical College
Division name
1)Division of cardiovascular disease, 2)Department of vascular surgery
Zip code
Address
1)3-1-69 Inabaso, Amagasaki, Hyogo, 660-8511,Japan2) 2-1-1-1 Midorigaoka-higashi , Asahikawa, Hokkaido 078-8510, Japan
TEL
06-6416-1221
iida.osa@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kaori Shimogama |
Organization
Japan Endovascular Treatment Conference
Division name
Office of WARRIORS Registry
Zip code
Address
7F, Fukuoka International College of Health and Welfare, 3-6-40, Momochihama, Sawara-ku, Fukuoka,814
TEL
092-834-2815
Homepage URL
secretariat@j-et.jp
Sponsor or person
Institute
Japan Endovascular Treatment Conference
Office of WARRIORS Registry
Institute
Department
Personal name
Funding Source
Organization
Japan Endovascular Treatment Conference
Office of WARRIORS Registry
Organization
Division
Category of Funding Organization
Non profit foundation
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
| 2017 | Year | 10 | Month | 13 | 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
Completed
Date of protocol fixation
| 2017 | Year | 08 | Month | 29 | Day |
Date of IRB
| 2017 | Year | 09 | Month | 26 | Day |
Anticipated trial start date
| 2017 | Year | 09 | Month | 26 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Prospective registry
Management information
Registered date
| 2017 | Year | 10 | Month | 13 | Day |
Last modified on
| 2024 | Year | 07 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033704
