UMIN-CTR Clinical Trial

Basic information
Public title	Assessment of maggot debridement therapy for leg ulcer
Acronym	Assessment of maggot debridement therapy for leg ulcer
Scientific Title	Assessment of maggot debridement therapy for leg ulcer
Scientific Title:Acronym	Assessment of maggot debridement therapy for leg ulcer
Region	Japan

Condition
Condition	Leg ulcer
Classification by specialty	Medicine in general
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Assessment of prognosis and efficacy for maggot debridement therapy
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Phase I,II

Assessment
Primary outcomes	Impact of maggot debridement therapy for severity and prognosis of leg ulcer
Key secondary outcomes	Clinical parameter in response to maggot debridement therapy

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	Medicine
Interventions/Control_1	Maggot debridement therapy: 48hr
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	Patient with leg ulcer
Key exclusion criteria	1) no evidence of leg ulcer, 2) unable to obtain informed consent, 3) smoker unable to quit smoking, 4) drug addiction of any kind (including alcohol), 5) complication of any serious disease affecting the patient's general condition
Target sample size	50

Research contact person
Last name of lead principal investigator	1st name Masaaki Middle name Last name Miyamoto
Organization	Nippon Medical School
Division name	Department of Cardiovascular Medicine
Zip code	113 8603
Address	1-1-5, Sendagi, Bunkyo-ku, Tokyo
TEL	03-3822-2131
Email	gen52@nms.ac.jp

Public contact
1st name of contact person	1st name Gen Middle name Last name Takagi
Organization	Nippon Medical School
Division name	Department of Cardiovascular Medicine
Zip code	113 8603
Address	1-1-5, Sendagi, Bunkyo-ku, Tokyo
TEL	03-3822-2131
Homepage URL
Email	miyamoto-m@nms.ac.jp

Sponsor
Institute	Nippon Medical School
Institute
Department

Funding Source
Organization	Department of Cardiovascular Medicine, Nippon Medical School
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	IRB-Nippon Medical School
Address	1-1-5, Sendagi, Bunkyo-ku, Tokyo
Tel	0338222131
Email	clinicaltrial@nms.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	日本医科大学付属病院（東京都）

Other administrative information
Date of disclosure of the study information	2011 Year 08 Month 15 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	Enrolling by invitation
Date of protocol fixation	2011 Year 08 Month 01 Day
Date of IRB
Anticipated trial start date	2011 Year 08 Month 01 Day
Last follow-up date	2012 Year 03 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2011 Year 08 Month 13 Day
Last modified on	2019 Year 03 Month 16 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000007286