UMIN-CTR Clinical Trial

Public title

An exploratory clinical trial using platelet-rich plasma in patients with chronic skin ulcers

Acronym

clinical trial using PRP in patients with chronic skin ulcers

Scientific Title

An exploratory clinical trial using platelet-rich plasma in patients with chronic skin ulcers

Scientific Title:Acronym

clinical trial using PRP in patients with chronic skin ulcers

Region

Japan

Condition

chronic skin ulcers

Classification by specialty

Dermatology

Plastic surgery

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

The purpose of this study is to examine the safety and effficacy of the platelet-rich plasma (PRP) in the treatment of chronic skin ulcers compared to those of the conventional therapy .

Basic objectives2

Bio-equivalence

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable

Primary outcomes

*Time until wound closure
The number of days from the administration of PRP to wound closure, spontaneous wound closure or wound closure by a simple surgical procedure is evaluated.

Key secondary outcomes

*Percentage of wound reduction
*The improvement of blood flow-The Skin perfusion pressure or Ankle brachial index
*The correlation of Time until wound closure to the platelet count or growth factor levels in PRP

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Historical

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Device,equipment

Interventions/Control_1

Activated Platelet-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

Age-lower limit

20

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

1.Patients aged 20 years or older at informed consent.
2.Written informed consent.
3.Presence of chronic skin ulcers not healing for at least 1 month with conventional treatments.
4.Expected to be closed by autologous skin grafting or suturing after PRP treatment

Key exclusion criteria

1.Patients showing unstable hemodynamics due to ischemic heart disease, or impair blood coagulation as in clotting disorders.
2.Patients taking anticoagulants or antithrombotics judged by the investigator or sub-investigator to be inappropriate as subjects since the drugs may affect the clotting system.
3.Have any of the following systemic diseases.
*Uncontrolled diabetes mellitus:HbA1c not lower than 10% according to latest laboratory data obtained within 28 days before registration
*Requiring continued use of oral corticosteroid therapy >20 mg/day prednisolone equivalent.
*A history of malignant tumor with disease-free interval of 3 years or less
4.Patients who are or may be pregnant
5.Other patients judged by the investigator or sub-investigator to be inappropriate as a subject of this study.

Target sample size

30

Name of lead principal investigator

1st name
Middle name
Last name	Kenji Kusumoto

Organization

Kansai Medical University

Division name

Department of Plastic and Reconstructive Surgery

Zip code

Address

2-5-1 Shin-machi, Hirakata City, Osaka,

TEL

0728040101

Email

prs@hirakata.kmu.ac.jp

Name of contact person

1st name
Middle name
Last name	Naoki Morimoto

Organization

Kansai Medical University

Division name

Department of Plastic and Reconstructive Surgery

Zip code

Address

2-5-1 Shin-machi, Hirakata City, Osaka

TEL

0728040101

Homepage URL

http://www.kmu.ac.jp/hirakata/

Email

morimotn@hirakata.kmu.ac.jp

Institute

Kansai Medical University

Institute

Department

Personal name

Organization

Kansai Medical University

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

関西医科大学附属枚方病院

Date of disclosure of the study information

2014

Year

11

Month

14

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Completed

Date of protocol fixation

2014

Year

07

Month

31

Day

Date of IRB

Anticipated trial start date

2014

Year

11

Month

14

Day

Last follow-up date

2015

Year

09

Month

30

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2014

Year

11

Month

14

Day

Last modified on

2015

Year

11

Month

24

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017643