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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000011439
Receipt No. 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 2013/08/10

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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
Email

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
Email miyanaga@kanazawa-med.ac.jp

Sponsor
Institute Kanazawa Medical University
Institute
Department

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
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
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 Open public recruiting
Date of protocol fixation
2013 Year 06 Month 25 Day
Date of IRB
Anticipated trial start date
2013 Year 08 Month 10 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
2013 Year 08 Month 10 Day
Last modified on
2013 Year 08 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013386

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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