UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000001045
Receipt number R000001252
Scientific Title Effects of bone marrow impregnated collagen matrix for treatments of chronic wounds
Date of disclosure of the study information 2008/02/20
Last modified on 2008/02/20 09:42:18

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Basic information

Public title

Effects of bone marrow impregnated collagen matrix for treatments of chronic wounds

Acronym

Effects of bone marrow impregnated collagen matrix for treatments of chronic wounds

Scientific Title

Effects of bone marrow impregnated collagen matrix for treatments of chronic wounds

Scientific Title:Acronym

Effects of bone marrow impregnated collagen matrix for treatments of chronic wounds

Region

Japan


Condition

Condition

Chronic wounds

Classification by specialty

Plastic surgery

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To describe and evaluate the treatment of chronic wounds using collagen impregnated collagen matrix.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Wound closure by spontaneous healing or skin graft

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Maneuver

Interventions/Control_1

Application of bone marrow impregnated collagen matrix

Interventions/Control_2

Standard wound care

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


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Chronic wounds that had not been healing for a period of at least 6 weeks with standard treatment

Key exclusion criteria

Patients were excluded if they had active infection, or malignant disease.. Written informed consent was obtained from all patients.

Target sample size

50


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Shigeru Ichioka

Organization

Saitama Medical University

Division name

Department of Plastic Surgery

Zip code


Address

38 Morohongo, Moroyama, Iruma-gun, Saitama, 350-0495

TEL


Email



Public contact

Name of contact person

1st name
Middle name
Last name

Organization

Saitama Medical University

Division name

Department of Plastic Surgery

Zip code


Address


TEL

049-276-1299

Homepage URL


Email



Sponsor or person

Institute

Saitama Medical University

Institute

Department

Personal name



Funding Source

Organization

Saitama Medical University

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

2008 Year 02 Month 20 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

2004 Year 08 Month 17 Day

Date of IRB


Anticipated trial start date

2004 Year 10 Month 01 Day

Last follow-up date

2007 Year 08 Month 01 Day

Date of closure to data entry

2008 Year 02 Month 01 Day

Date trial data considered complete

2008 Year 02 Month 01 Day

Date analysis concluded

2008 Year 02 Month 01 Day


Other

Other related information



Management information

Registered date

2008 Year 02 Month 20 Day

Last modified on

2008 Year 02 Month 20 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001252


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name