UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024012 |
|---|---|
| Receipt number | R000027650 |
| Scientific Title | The usefulness and development of maggots therapy |
| Date of disclosure of the study information | 2016/09/12 |
| Last modified on | 2023/09/22 11:15:43 |
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Basic information
Public title
The usefulness and development of maggots therapy
Acronym
The usefulness and development of maggots therapy
Scientific Title
The usefulness and development of maggots therapy
Scientific Title:Acronym
The usefulness and development of maggots therapy
Region
| Japan |
Condition
Condition
intractable ulcer
Classification by specialty
| Plastic surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In order to verify the safety and efficacy of sterile maggots therapy for intractable ulcer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The presence or absence of adverse events, healing period
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
| Other |
Interventions/Control_1
Maggot therapy group
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients with intractable ulcer
Key exclusion criteria
Tumor-bearing patients
Target sample size
5
Research contact person
Name of lead principal investigator
| 1st name | Toshikatsu |
| Middle name | |
| Last name | Igata |
Organization
Kumamoto University
Division name
Department of Dermatology and Plastic Surgery
Zip code
8608556
Address
1-1-1-honjo-kumamoto-kumamoto-860-8556-japan
TEL
096-373-5233
t-igata@ten-sun.net
Public contact
Name of contact person
| 1st name | Toshikatsu |
| Middle name | |
| Last name | Igata |
Organization
Kumamoto University
Division name
Department of Dermatology and Plastic Surgery
Zip code
8608556
Address
1-1-1-honjo-kumamoto-kumamoto-860-8556-japan
TEL
096-373-5233
Homepage URL
t-igata@ten-sun.net
Sponsor or person
Institute
Kumamoto University
Institute
Department
Personal name
Funding Source
Organization
Kumamoto University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
kumamoto univ. hospital
Address
kumamoto-shi, honjo 1-1-1
Tel
0963442111
t-igata@ten-sun.net
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
| 2016 | Year | 09 | Month | 12 | 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
0
Results
Number of participants that the trial has enrolled is zero.
Results date posted
| 2023 | Year | 09 | Month | 22 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Number of participants that the trial has enrolled is zero.
Participant flow
Number of participants that the trial has enrolled is zero.
Adverse events
none
Outcome measures
Number of participants that the trial has enrolled is zero.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Terminated
Date of protocol fixation
| 2014 | Year | 07 | Month | 10 | Day |
Date of IRB
| 2014 | Year | 03 | Month | 24 | Day |
Anticipated trial start date
| 2014 | Year | 07 | Month | 10 | Day |
Last follow-up date
| 2019 | Year | 09 | Month | 21 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 09 | Month | 12 | Day |
Last modified on
| 2023 | Year | 09 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027650
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
