UMIN-CTR Clinical Trial

Basic information
Public title	The relationship between the patency rate of infrapopliteal lesions after endovascular treatment and wound healing rate in critical limb ischemia with tissue loss
Acronym	the patency rate of infrapopliteal lesions after endovascular treatment and wound healing rate in critical limb ischemia
Scientific Title	The relationship between the patency rate of infrapopliteal lesions after endovascular treatment and wound healing rate in critical limb ischemia with tissue loss
Scientific Title:Acronym	the patency rate of infrapopliteal lesions after endovascular treatment and wound healing rate in critical limb ischemia
Region	Japan

Condition
Condition	critical limb ischemia
Classification by specialty	Cardiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the relationship between the patency of infrapopliteal lesions assessed by echography after endovascular treatment and wound healing in critical limb ischemia with tissue loss
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The patency rate of infrapopliteal lesions and wound healing rate at 1, 2, 3, 6, and 12 months after endovascular treatment
Key secondary outcomes	major amputation free rate, major amputation free survival rate

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	18 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Critical limb ischemia patients with tissue loss who are aged 18 years or older
Key exclusion criteria	Patients who may not complete 1 year follow-up
Target sample size	50

Research contact person
Name of lead principal investigator	1st name Norihiro Middle name Last name Kobayashi
Organization	Saiseikai Yokohama-city Eastern Hospital
Division name	Cardiology
Zip code	230-8765
Address	3-6-1 Shimosueyoshi, Tsurumi-ku, Yokohama, Kanagawa
TEL	045-576-3000
Email	ovation17@gmail.com

Public contact
Name of contact person	1st name Norihiro Middle name Last name Kobayashi
Organization	Saiseikai Yokohama-city Eastern Hospital
Division name	Cardiology
Zip code	230-8765
Address	3-6-1 Shimosueyoshi, Tsurumi-ku, Yokohama, Kanagawa
TEL	045-576-3000
Homepage URL
Email	ovation17@gmail.com

Sponsor
Institute	Saiseikai Yokohama-city Eastern Hospital
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Saiseikai Yokohama-city Eastern Hospital
Address	3-6-1 Shimosueyoshi, Tsurumi-ku, Yokohama, Kanagawa
Tel	045-576-3000
Email	045-576-3000

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 01 Month 05 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	Preinitiation
Date of protocol fixation	2014 Year 12 Month 20 Day
Date of IRB
Anticipated trial start date	2015 Year 01 Month 05 Day
Last follow-up date	2020 Year 02 Month 28 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	To investigate the relationship between the patency of infrapopliteal lesions assessed by echography after endovascular treatment and wound healing rate in critical limb ischemia with tissue loss

Management information
Registered date	2015 Year 01 Month 02 Day
Last modified on	2021 Year 01 Month 06 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000018696