UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The Healing Effects of Platelet- Rich Plasma on refractory cutaneous uclers
Title of the study (Brief title)	The Healing Effects of Platelet- Rich Plasma on refractory cutaneous uclers
Region	Japan

Condition
Condition	refractory cutaneous uclers
Classification by specialty	Dermatology Plastic surgery
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study is to examine the efficacy and safety of the treatment using the platelet-rich plasma(PRP) to intractable skin ulcers.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Time to wound closure (days) We evaluate the length of time (days) from the administration of PRP to full-epithelialization or to when the wound become closed by a simple surgical closure.
Key secondary outcomes	We evaluate side reaction such as wound healing delayed, excessive inflammation about treatment with platelet-rich plasma.

Base
Study type	Interventional

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

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Other
Interventions/Control_1	<platelet-rich plasma> We administer PRP(1-several cc)to the wound in a single dose according to size of the wounded area and evaluate effect of treatment at 1,2,4,6 and 8 weeks after initiation of the therapy. Additional administration of PRP is considered after having obtained patient's consent after start of therapy depending on a state of the wounded area every two weeks. As for the observation and the duration of treatment, we do it with eight weeks, but extend this period to limit in 16 weeks when it shows an effect, and subjects hope for continuation of this treatment.
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	1)Patients aged 18 over or older at informed consent.Written informed consent. 2)Patient with intractable cutaneous ulcer without the improvement or with the exacerbation by a conventional therapy. 3)Patients who have difficulty in treatment with surgery due to physical states. 4)Patients during ambulatory care,
Key exclusion criteria	1) Patients with severe anemia (7 g/dl of Hb or less) 2)Patients with thrombocytopenia(less than Plt 150,000/ul) 3)Other patients judged by the investigator to be inappropriate as subjects of this study. 4)The hospitalized patients.
Target sample size	15

Research contact person
Name of lead principal investigator	Kazuhiko Takehara
Organization	Kanazawa University
Division name	Department of Dermatology
Address	13-1 Takaramachi,Kanazawa,Ishikawa
TEL	07622652342
Email	hifuka-jimu@med.kanazawa-u.ac.jp

Public contact
Name of contact person	Akito Komuro
Organization	Kanazawa University
Division name	Division of Plastic and Reconstructive Surgery,Department of Dermatology
Address	13-1 Takaramachi,Kanazawa,Ishikawa
TEL	07622652342
Homepage URL
Email	komuro@kanazawa-med.ac.jp

Sponsor
Institute	Kanazawa University
Institute
Department

Funding Source
Organization	Kanazawa University
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

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 02 Month 17 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2014 Year 10 Month 28 Day
Anticipated trial start date	2015 Year 02 Month 23 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 02 Month 16 Day
Last modified on	2017 Year 08 Month 19 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000023592