UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000008428
Receipt number R000009913
Scientific Title Platelet-rich Plasma treatment of refractory ulcers with hyaluronic acid scaffolds
Date of disclosure of the study information 2012/07/26
Last modified on 2022/05/23 11:25:01

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Basic information

Public title

Platelet-rich Plasma treatment of refractory ulcers with hyaluronic acid scaffolds

Acronym

PRP treatment of ulcers with HA scaffolds

Scientific Title

Platelet-rich Plasma treatment of refractory ulcers with hyaluronic acid scaffolds

Scientific Title:Acronym

PRP treatment of ulcers with HA scaffolds

Region

Japan


Condition

Condition

Refractory ulcers, Foot ulcers

Classification by specialty

Cardiology Vascular surgery Dermatology
Plastic surgery

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the efficacy and safety of PRP tretment of refractory ulcers.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

reduction ratio of wound area

Key secondary outcomes

period for complete wound closure, mean times of PRP application, mean platelet concentration, pathological examination of granulation tissue, epithelialization of wound margin, etc.


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

NO

Dynamic allocation

NO

Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine Maneuver

Interventions/Control_1

Local injection of PRP with hyaluronic acid scaffolds together with standard therapy using ointment and dressing materials

Interventions/Control_2

Standard therapy using ointment and dressing materials

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

85 years-old >=

Gender

Male and Female

Key inclusion criteria

1.Chronic or unstable skin ulcer

2.Written informed consent by patient himself

Key exclusion criteria

1.anemia
2.thrombocytopenia
3.local infection
4.malignancy

Target sample size

20


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Takanobu MASHIKO

Organization

Saitama Medical Center

Division name

Plasctic and Cosmetic Surgery

Zip code


Address

1981Kamoda, Kawagoe, Saitama

TEL

049-228-3400

Email

takanobu-mashiko@umin.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Takanobu MASHIKO

Organization

Saitama Medical Center

Division name

Plasctic and Cosmetic Surgery

Zip code


Address

1981Kamoda, Kawagoe, Saitama

TEL

049-228-3400

Homepage URL


Email

takanobu-mashiko@umin.ac.jp


Sponsor or person

Institute

Saitama Medical Center

Institute

Department

Personal name



Funding Source

Organization

Saitama Medical Center

Organization

Division

Category of Funding Organization

Local Government

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

2012 Year 07 Month 26 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

2012 Year 07 Month 26 Day

Date of IRB

2012 Year 07 Month 26 Day

Anticipated trial start date

2012 Year 07 Month 26 Day

Last follow-up date

2014 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2012 Year 07 Month 13 Day

Last modified on

2022 Year 05 Month 23 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009913


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name