UMIN-CTR Clinical Trial

Basic information
Public title	Therapy of refractive skin ulcer by using platelet rich plasma
Acronym	Treatment of ulcer by PRP
Scientific Title	Therapy of refractive skin ulcer by using platelet rich plasma
Scientific Title:Acronym	Treatment of ulcer by PRP
Region	Japan

Condition
Condition	decubitus and refractive skin ulcer(excepting cosmetic surgery)
Classification by specialty	Dermatology Orthopedics Cardiovascular surgery Plastic surgery
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Regenerative medicine for refractive skin ulser
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	wound heeling with reepithelization after 8 weeks.
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	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	administration(once a week, Max 8 times) dosage(1mL of ten folds concentrated plate-rich plasma)
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	To meet all of the following conditions. 1) no effect on FGF-2 or occulutive negative pressure treatment for 28 days. 2) case of reject following therapy a. amptation b. skin graft c. other surgical approach 3) ill systemic condition for operation 4) patient who can collect the venous blood for PRP production 5) over 20 years old 6) patient who can take a informed consent
Key exclusion criteria	If any of the following items. 1) patients who can not control the infection of the wound surface. 2) the wound surface (ulcer) with malignancy 3) significant anemia (both men and women less than Hb 7g / dL) 4) leukemia 5) aplastic anemia 6) thrombocytopenia 7) blood coregration abnormality 8) no compliance 9) no agreement
Target sample size	23

Research contact person
Name of lead principal investigator	1st name Middle name Last name Masaki Aihara
Organization	St.Marianna University School of Medecine
Division name	Dept. of Plastic and Reconstructive Surgery
Zip code
Address	2-16-1 Sugao, Miyamae, Kawasaki, JAPAN
TEL	044-977-8111
Email	m2aihara@marianna-u.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Hajime Inoue
Organization	St.Marianna University School of Medecine
Division name	Dept. of Plastic and Reconstructive Surgery, Div. of Stem Cell Medecine
Zip code
Address	2-16-1 Sugao, Miyamae, Kawasaki, JAPAN
TEL	044-977-8111
Homepage URL
Email	h2inoue@marianna-u.ac.jp

Sponsor
Institute	St.Marianna University School of Medecine Dept. of Plastic and Reconstructive Surgery, Div. of Stem Cell Medecine
Institute
Department

Funding Source
Organization	St.Marianna University School of Medecine Dept. of Plastic and Reconstructive Surgery, Div. of Stem Cell Medecine
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
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	2016 Year 09 Month 07 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	2015 Year 12 Month 05 Day
Date of IRB	2016 Year 01 Month 26 Day
Anticipated trial start date	2016 Year 01 Month 01 Day
Last follow-up date	2019 Year 06 Month 17 Day
Date of closure to data entry	2019 Year 06 Month 30 Day
Date trial data considered complete	2019 Year 07 Month 31 Day
Date analysis concluded	2019 Year 08 Month 26 Day

Other
Other related information

Management information
Registered date	2016 Year 09 Month 07 Day
Last modified on	2019 Year 09 Month 10 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000027592