Unique ID issued by UMIN | UMIN000030694 |
---|---|
Receipt number | 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 20:53:24 |
An investigator-initiated exploratory clinical trial for refractory skin ulcer of lower leg using silk-elastin sponge (P47K-WAS) to evaluate the safety
An exploratory clinical trial for refractory skin ulcer of lower leg using silk-elastin sponge (ECRUS)
An investigator-initiated exploratory clinical trial for refractory skin ulcer of lower leg using silk-elastin sponge (P47K-WAS) to evaluate the safety
An exploratory clinical trial for refractory skin ulcer of lower leg using silk-elastin sponge (ECRUS)
Japan |
Refractory skin ulcer of lower leg
Plastic surgery |
Others
NO
To assess the safety of overlaying a silk-elastin sponge on lower leg skin ulcers that have not healed with conventional therapy
Safety
Exploratory
Explanatory
Phase I,II
Incidence of adverse events and reactions
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
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Device,equipment |
Sponge containing 12.5 mg/cm2 silk-elastin will be administered once and be kept for 14 days.
20 | years-old | <= |
Not applicable |
Male and Female
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.
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.
6
1st name | |
Middle name | |
Last name | Kazuo Noda |
Kyoto University Hospital
Department of Plastic and Reconstructive Surgery
54 Kawaharacho, Shogoin, Sakyo-ku, Kyoto 606-8507, Japan
+81-75-751-3613
ecrus_office@kuhp.kyoto-u.ac.jp
1st name | |
Middle name | |
Last name | Kazuo Noda |
Kyoto University Hospital
Department of Plastic and Reconstructive Surgery
54 Kawaharacho, Shogoin, Sakyo-ku, Kyoto 606-8507, Japan
+81-75-751-3613
ecrus_office@kuhp.kyoto-u.ac.jp
Department of Plastic and Reconstructive Surgery,
Kyoto University Hospital
Japan Agency for Medical Research and Development (AMED)
Japanese Governmental office
Japan
NO
京都大学医学部附属病院(京都府)
2018 | Year | 01 | Month | 05 | Day |
Unpublished
Completed
2017 | Year | 11 | Month | 30 | Day |
2018 | Year | 03 | Month | 01 | Day |
2018 | Year | 01 | Month | 05 | Day |
2019 | Year | 01 | Month | 09 | Day |
Value
https://center6.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 |