UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005672 |
|---|---|
| Receipt number | R000006700 |
| Scientific Title | Topical oxygen therapy for chronic ulcers and postoperative wounds |
| Date of disclosure of the study information | 2011/06/01 |
| Last modified on | 2011/05/30 15:29:28 |
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Basic information
Public title
Topical oxygen therapy for chronic ulcers and postoperative wounds
Acronym
Topical oxygen therapy for chronic ulcers and postoperative wounds
Scientific Title
Topical oxygen therapy for chronic ulcers and postoperative wounds
Scientific Title:Acronym
Topical oxygen therapy for chronic ulcers and postoperative wounds
Region
| Japan |
Condition
Condition
Non-healing wounds
Classification by specialty
| Plastic surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Non-healing wounds with diabetic mellitus and/or peripheral artery disease (PAD) show high rates of complications, and a major risk factor for lower extremity amputation. In these cases, local tissue hypoxia, caused by disrupted or compromised vasculature, is a key factor that limits wound healing and topical infection control. Reconstructive surgical techniques to close these wounds frequently suffer serious complications, including flap necrosis and infection.
Oxygen plays an essential role in the metabolism, the matrix synthesis, infection control and cell migration and proliferation. Topical oxygen application might be effective to promote wound healing and suppress the bacterial growth.This study aims to examine the clinical efficacy of topical oxygen therapy in patients with non-healing ulcers and/or postoperative wounds
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Bacterial culture
Topical oxygen tension (TcPO2)
Skin perfusion pressure (SPP)
Key secondary outcomes
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
| Device,equipment |
Interventions/Control_1
chronic wounds
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
chronic wounds
Key exclusion criteria
malignancy
Target sample size
20
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 and Reconstructive Surgery
Zip code
Address
38 Morohongo, Moroyama, Iruma-gun, Saitama
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Saitama medical university
Division name
Department of Plastic and Reconstructive Surgery
Zip code
Address
TEL
Homepage URL
sasasa116sasasa@hotmail.com
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
| 2011 | Year | 06 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
Enrolling by invitation
Date of protocol fixation
| 2010 | Year | 10 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 10 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2011 | Year | 05 | Month | 30 | Day |
Last modified on
| 2011 | Year | 05 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006700
