UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011439 |
|---|---|
| Receipt number | R000013386 |
| Scientific Title | Evaluation of medical sterile maggot therapy on intractable gangrene and ulcer. |
| Date of disclosure of the study information | 2013/08/10 |
| Last modified on | 2022/09/29 08:33:22 |
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Basic information
Public title
Evaluation of medical sterile maggot therapy on intractable gangrene and ulcer.
Acronym
MDT (Maggot Debridement Therapy) Study
Scientific Title
Evaluation of medical sterile maggot therapy on intractable gangrene and ulcer.
Scientific Title:Acronym
MDT (Maggot Debridement Therapy) Study
Region
| Japan |
Condition
Condition
Intractable gangrene and ulcer.
Classification by specialty
| Plastic surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of the effect and safety of medical sterile maggot on intractable gangrene and ulcer.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The size of necrosis.
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
Medical sterile maggot
(Biotherapy Medical Co., Ltd)
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Patients who will be able to obtain written informed consent.
Key exclusion criteria
1. Patients whom internal organs and/or large blood vessels has exposed from the wound.
2. Patients who have the osteomyelitis.
3. Patients who have risk of severe liver failure and/or brain dysfunction.
4. Cannot be obtained the consent of the patient and family.
5. Patients who were judged to be inappropriate by the investigator.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toru Miyanaga |
Organization
Kanazawa Medical University
Division name
Plastic and Reconstructive Surgery
Zip code
Address
1-1 Daigaku, Uchinada, Kahoku, Ishikawa
TEL
076-286-2211
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Toru Miyanaga |
Organization
Kanazawa Medical University
Division name
Plastic and Reconstructive Surgery
Zip code
Address
1-1 Daigaku, Uchinada, Kahoku, Ishikawa
TEL
Homepage URL
miyanaga@kanazawa-med.ac.jp
Sponsor or person
Institute
Kanazawa Medical University
Institute
Department
Personal name
Funding Source
Organization
Kanazawa 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
| 2013 | Year | 08 | Month | 10 | 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
| 2013 | Year | 06 | Month | 25 | Day |
Date of IRB
| 2013 | Year | 07 | Month | 31 | Day |
Anticipated trial start date
| 2013 | Year | 08 | Month | 10 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 02 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 08 | Month | 10 | Day |
Last modified on
| 2022 | Year | 09 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013386
