UMIN-CTR Clinical Trial

Basic information
Public title	Establishment of Regenerative Therapy for Intractable Wound
Acronym	Regenerative Therapy for Wound Healing
Scientific Title	Establishment of Regenerative Therapy for Intractable Wound
Scientific Title:Acronym	Regenerative Therapy for Wound Healing
Region	Japan

Condition
Condition	Intractable peripheral artery disease (arteriosclerosis obliterans and thronboangiitis obliterans) and intractable skin ulcer
Classification by specialty	Cardiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Wound healing effect by controlled release platelet rich plasma (PRP) regenerative therapy
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Explanatory
Developmental phase	Phase I,II

Assessment
Primary outcomes	Efficacy determination by the changes of wound size and granulation recovery 4 weeks after treatment or termination period
Key secondary outcomes	Major adverse event and resting pain

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	YES
Dynamic allocation	YES
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	Numbered container method

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Platelet rich plasma(PRP) will be prepared from autologous peripheral blood sample. Autologous PRP 1.8ml will be impregnated with biodegradable gelatin microsphere (180mg). Prepared controlled release PRP will be injected into the muscle by 10 points.
Interventions/Control_2	Hyperbaric oxygen therapy will be performed(every day to 3times per week until 20 times will be terminated).
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	Intractable ulcer due to any cause, which complicated with disability of daily life. Intractable by means out of indication or no response to conventional medical treatment at least 3 months.
Key exclusion criteria	Any infections by osteomyelitis or multiple resistant bacteria, which unable to control by antibiotics alone. Any malignant disease, which was treated within 5 years. Who need treatment (surgical approach) in addition to present treatment.
Target sample size	24

Research contact person
Last name of lead principal investigator	1st name Gen Middle name Last name Takagi
Organization	Nippon Medical School
Division name	Department of Cardiovascular Medicine
Zip code	113 8603
Address	1-1-5, Sendagi, Bunkyo-ku, Tokyo. Japan
TEL	03-3822-2131
Email	gen52@nms.ac.jp

Public contact
1st name of contact person	1st name Gen Middle name Last name Takagi
Organization	Nippon Medical School
Division name	Department of Cardiovascular Medicine
Zip code	113 8603
Address	1-1-5, Sendagi, Bunkyo-ku, Tokyo. Japan
TEL	03-3822-2131
Homepage URL
Email	gen52@nms.ac.jp

Sponsor
Institute	Department of Cardiovascular Medicine, Nippon Medical School
Institute
Department

Funding Source
Organization	JSPS-Kakenhi
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor	None
Name of secondary funder(s)	None

IRB Contact (For public release)
Organization	IRB-Nippon Medical School
Address	1-1-5, Sendagi, Bunkyo-ku, Tokyo
Tel	03-3822-2131
Email	inq-ccr@nms.ac.jp

Secondary IDs
Secondary IDs	YES
Study ID_1	NB3150006
Org. issuing International ID_1	The Japanese Association for the Promotion of State-of-the-Art in Medicine (JAPSAM)
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	日本医科大学付属病院（東京都）

Other administrative information
Date of disclosure of the study information	2016 Year 07 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
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	Open public recruiting
Date of protocol fixation	2015 Year 11 Month 23 Day
Date of IRB
Anticipated trial start date	2016 Year 07 Month 25 Day
Last follow-up date	2019 Year 07 Month 24 Day
Date of closure to data entry	2019 Year 12 Month 31 Day
Date trial data considered complete	2019 Year 12 Month 31 Day
Date analysis concluded	2019 Year 12 Month 31 Day

Other
Other related information

Management information
Registered date	2016 Year 07 Month 22 Day
Last modified on	2019 Year 03 Month 16 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000026846