UMIN-CTR Clinical Trial

Basic information
Public title	The effects of transdemal glycerol trinitrate administration on the ischemic limb for vascular intermittent claudication
Acronym	Transdemal glycerol trinitrate administration on the ischemic limb
Scientific Title	The effects of transdemal glycerol trinitrate administration on the ischemic limb for vascular intermittent claudication
Scientific Title:Acronym	Transdemal glycerol trinitrate administration on the ischemic limb
Region	Japan

Condition
Condition	peripheral arterial disease
Classification by specialty	Cardiology Vascular surgery
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the effects of transdermal administration of glycerol trinitrate (GTN) tape on the calf blood flow of the ischemic limbs in 32 patients having intermittent claudication due to peripheral arterial disease.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	resting and post-exercise calf blood flow, pain-free and maximum exercise times
Key secondary outcomes

Base
Study type	Interventional

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

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	transdermal administration of glycerol trinitrate tape on the ischemic limbs/ on the chest
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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	patients having intermittent claudication due to peripheral arterial disease
Key exclusion criteria	1 Patients who can not do ankle exercise 2 Patients with severe cardiac or respiratory dysfunction 3 Patients that can not be stopped oral intake and medications 4 Patients with hypersensitivity to glycerol trinitrate tape 5 Patients with history of glycerol trinitrate adverse effect 6 Patient with lower limb paralysis 7 Patients are registered in other trials
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Middle name Last name Akira Sato
Organization	Graduate School of Medicine Tohoku University
Division name	Division of Advanced surgical Science and Technology
Zip code
Address	1-1, Seiryo-machi, Aoba-ku Sendai, 980-8574 Japan
TEL	022-717-7214
Email

Public contact
Name of contact person	1st name Middle name Last name Akira Sato
Organization	Graduate School of Medicine Tohoku University
Division name	Division of Advanced surgical Science and Technology
Zip code
Address
TEL	022-717-7214
Homepage URL
Email	attkas@med.tohoku.ac.jp

Sponsor
Institute	Division of Advanced surgical Science and Technology
Institute
Department

Funding Source
Organization	Division of Advanced surgical Science and Technology
Organization
Division
Category of Funding Organization
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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	2010 Year 06 Month 04 Day

Related information
URL releasing protocol
Publication of results	Partially published

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	2009 Year 09 Month 28 Day
Date of IRB
Anticipated trial start date	2009 Year 10 Month 01 Day
Last follow-up date	2010 Year 05 Month 01 Day
Date of closure to data entry	2010 Year 06 Month 01 Day
Date trial data considered complete	2010 Year 06 Month 01 Day
Date analysis concluded	2010 Year 09 Month 01 Day

Other
Other related information

Management information
Registered date	2010 Year 06 Month 04 Day
Last modified on	2011 Year 05 Month 26 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004470

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

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