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
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
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
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
