UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000022258
Receipt number R000025648
Scientific Title clinical trial of platelet rich plasma for the treatment of chronic cutaneous ulcers
Date of disclosure of the study information 2016/05/16
Last modified on 2017/05/12 16:50:14

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Basic information

Public title

clinical trial of platelet rich plasma for the treatment of chronic cutaneous ulcers

Acronym

PRP for the treatment of cutaneous ulcers

Scientific Title

clinical trial of platelet rich plasma for the treatment of chronic cutaneous ulcers

Scientific Title:Acronym

PRP for the treatment of cutaneous ulcers

Region

Japan


Condition

Condition

chronic cutaneous ulcer

Classification by specialty

Dermatology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate effectiveness and safety of autologous platelet rich plasma for the treatment of chronic cutaneous ulcers

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

More than 50 per cent epithelialization after 4 or 8 week

Key secondary outcomes

Per cent of ulcer decrease in area


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

Other

Interventions/Control_1

Application of PRP to ulcer

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

Patient with an ulcer of at least one month's duration

Key exclusion criteria

Screening platelet count < 150 x 109/L
Uncontrolled infection at under
Patient has active cancer
Screening hemoglobin <8.0 mg/dL

Target sample size

3


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Takeshi Nakanishi

Organization

Shiga University of Medical Science

Division name

Dermatology

Zip code


Address

Seta-tsukinowa, Otsu city, Shiga Japan

TEL

81-77-548-2381

Email

tnderma@belle.shiga-med.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Takeshi Nakanishi

Organization

Shiga University of Medical Science

Division name

Dermatology

Zip code


Address

Seta-tsukinowa, Otsu city, Shiga Japan

TEL

81-77-548-2381

Homepage URL


Email

tnderma@belle.shiga-med.ac.jp


Sponsor or person

Institute

Shiga University of Medical Science

Institute

Department

Personal name



Funding Source

Organization

Shiga University of Medical Science

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 05 Month 16 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

2 subjects,
effectiveness:1 effective, 1 not effective
safety:no problem

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

2016 Year 05 Month 10 Day

Date of IRB


Anticipated trial start date

2016 Year 05 Month 16 Day

Last follow-up date

2016 Year 06 Month 27 Day

Date of closure to data entry

2016 Year 06 Month 29 Day

Date trial data considered complete

2016 Year 12 Month 28 Day

Date analysis concluded



Other

Other related information



Management information

Registered date

2016 Year 05 Month 10 Day

Last modified on

2017 Year 05 Month 12 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025648


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name