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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000030694
Receipt No. R000035024
Scientific Title An investigator-initiated exploratory clinical trial for refractory skin ulcer of lower leg using silk-elastin sponge (P47K-WAS) to evaluate the safety
Date of disclosure of the study information 2018/01/05
Last modified on 2019/01/09

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Basic information
Public title An investigator-initiated exploratory clinical trial for refractory skin ulcer of lower leg using silk-elastin sponge (P47K-WAS) to evaluate the safety
Acronym An exploratory clinical trial for refractory skin ulcer of lower leg using silk-elastin sponge (ECRUS)
Scientific Title An investigator-initiated exploratory clinical trial for refractory skin ulcer of lower leg using silk-elastin sponge (P47K-WAS) to evaluate the safety
Scientific Title:Acronym An exploratory clinical trial for refractory skin ulcer of lower leg using silk-elastin sponge (ECRUS)
Region
Japan

Condition
Condition Refractory skin ulcer of lower leg
Classification by specialty
Plastic surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To assess the safety of overlaying a silk-elastin sponge on lower leg skin ulcers that have not healed with conventional therapy
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Phase I,II

Assessment
Primary outcomes Incidence of adverse events and reactions
Key secondary outcomes 1. The occupancy of granulation tissue
2. The rate of ulcer area reduction
3. Incidence of clinical observation for local infection
4. The rate for completion of 7 and 14 days after overlaying silk-elastin sponge

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 Sponge containing 12.5 mg/cm2 silk-elastin will be administered once and be kept for 14 days.
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 1)Four-week healing rate is under 50%.
2)An ulcer under knee joint.
3)An ulcer area is between 2 and 25 cm2.
4)An ulcer covered by an investigational device is able to be sealed with polyurethane film.
5)No other ulcers within 5 cm around the ulcer.
6)No local infection of the ulcer.
7)Bone exposure area is under 10% of the ulcer area.
8)Skin perfusion pressure of the affected leg is 30 mmHg or more.
Key exclusion criteria 1)Patients are ages under 20 when they consent to participate in this trial.
2)Women who are or may be pregnant. Women who are nursing. Women who do not consent to use contraception during this trial.
3)Patients with previous histories of allergy for silk, urethane, and the reagent used in this trial, such as local anesthetics and disinfectant.
4)Patients with any of the following conditions:
*Poorly controlled diabetes (>=10% of HbA1c in latest laboratory findings within 28 days before enrollment).
*Patients recieving hemodialysis or peritonial dialysis.
*Patients being treated of malignancy.
*Patients requiring continuous systemic administration of steroids (a dose exceeding an equivalent predonisolone dose of 10 mg/day).
5)Patients who have participated in another clinical trial within 3 months before enrollment.
6)Patients who have participated in this trial and administered with an investigational device.
7)Patients are not able to provide consent to participate in this trial in writing.
8)Other individuals whom an investigator or sub-investigator deems inappropriate for participation in this trial.
Target sample size 6

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kazuo Noda
Organization Kyoto University Hospital
Division name Department of Plastic and Reconstructive Surgery
Zip code
Address 54 Kawaharacho, Shogoin, Sakyo-ku, Kyoto 606-8507, Japan
TEL +81-75-751-3613
Email ecrus_office@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kazuo Noda
Organization Kyoto University Hospital
Division name Department of Plastic and Reconstructive Surgery
Zip code
Address 54 Kawaharacho, Shogoin, Sakyo-ku, Kyoto 606-8507, Japan
TEL +81-75-751-3613
Homepage URL
Email ecrus_office@kuhp.kyoto-u.ac.jp

Sponsor
Institute Department of Plastic and Reconstructive Surgery,
Kyoto University Hospital
Institute
Department

Funding Source
Organization Japan Agency for Medical Research and Development (AMED)
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization Japan

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 京都大学医学部附属病院(京都府)

Other administrative information
Date of disclosure of the study information
2018 Year 01 Month 05 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
2017 Year 11 Month 30 Day
Date of IRB
Anticipated trial start date
2018 Year 03 Month 01 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
2018 Year 01 Month 05 Day
Last modified on
2019 Year 01 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035024

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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