UMIN-CTR Clinical Trial

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
Email	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
Email	mkishibe@asahikawa-med.ac.jp

Sponsor
Institute	Asahikawa Medical University
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000021734