UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018861 |
|---|---|
| Receipt number | R000021734 |
| Scientific Title | Maggot therapy using medical aseptic flies larvae for refractory chronic skin ulcer |
| Date of disclosure of the study information | 2015/08/31 |
| Last modified on | 2021/09/04 17:05:09 |
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Basic information
Public title
Maggot therapy using medical aseptic flies larvae for refractory chronic skin ulcer
Acronym
Maggot therapy for chronic skin ulcer
Scientific Title
Maggot therapy using medical aseptic flies larvae for refractory chronic skin ulcer
Scientific Title:Acronym
Maggot therapy for chronic skin ulcer
Region
| Japan |
Condition
Condition
1.Diabetic ulcer or Diabetic gangrene,2.Decubitus, 3. Leg ulcer due to ischemia, stasis, systemic sclerosis etc.
Classification by specialty
| Dermatology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess if the maggot therapy promote healing refractory chronic skin ulcer to shorten therapeutic time and improve QOL.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1.Ulcer size and depth,2.Pain assessment using visual analog scale, 3.Blood test,4.Bacterial culture,5.The therapy will 6.The therapy will be finished when the ulcer seems to be closed by skin grafts. Those assessment will be performed before treatment and 2,3,4,5 weeks and 6 months after treatment.
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
medical aseptic flies larvae
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
Untraceable chronic skin ulcer due to diabetic ulcer or diabetic gangrene, Decubitus, leg ulcer due to ischemia, stasis, and systemic sclerosis etc.
Key exclusion criteria
1. Patient who is not accepted the maggot therapy, 2. Severe blood flow obstruction, 3. Rapid exacerbated infection, 4. Poorly controlled collagen vascular disease, 5. Visible large vessels can be detected on the ulcer or connected to inside of the body, 6. Uncontrolled hemorrhagic disease, 7. Sensitivity for medical maggot. 8. In appropriate case judged by a doctor.
Target sample size
3
Research contact person
Name of lead principal investigator
| 1st name | Satomi |
| Middle name | |
| Last name | Igawa |
Organization
Asahikawa Medical University
Division name
Dermatology
Zip code
0788510
Address
Midorigaoka Higashi 2-1-1-1, Asahikawa
TEL
0166-68-2523
igasato@asahikawa-med.ac.jp
Public contact
Name of contact person
| 1st name | Mari |
| Middle name | |
| Last name | Kishibe |
Organization
Asahikawa Medical University
Division name
Dermatology
Zip code
078-8510
Address
Midorigaoka Higashi 2-1-1-1, Asahikawa
TEL
0166-68-2523
Homepage URL
mkishibe@asahikawa-med.ac.jp
Sponsor or person
Institute
Asahikawa Medical University
Institute
Department
Personal name
Funding Source
Organization
Department of Dermatology, Asahikawa Medical 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
Asahikawa Medical University
Address
Midorigaoka-Higashi 2-1-1-1, Asahikawa, Hokkaido
Tel
0166-68-2297
rs-kk.g@asahikawa-med.ac.jp
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
| 2015 | Year | 08 | Month | 31 | 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
1
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
| 2015 | Year | 07 | Month | 28 | Day |
Date of IRB
| 2015 | Year | 07 | Month | 28 | Day |
Anticipated trial start date
| 2015 | Year | 10 | Month | 02 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2021 | Year | 09 | Month | 04 | Day |
Date trial data considered complete
| 2021 | Year | 09 | Month | 10 | Day |
Date analysis concluded
| 2021 | Year | 09 | Month | 10 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 08 | Month | 31 | Day |
Last modified on
| 2021 | Year | 09 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021734
