UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044964 |
|---|---|
| Receipt number | R000047434 |
| Scientific Title | Special Drug Use Investigation in patients with critical lower limb ischemia under conservative treatment |
| Date of disclosure of the study information | 2021/07/31 |
| Last modified on | 2023/12/19 12:42:51 |
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Basic information
Public title
Special Drug Use Investigation in patients with critical lower limb ischemia under conservative treatment
Acronym
Special Drug Use Investigation in patients with critical lower limb ischemia under conservative treatment
Scientific Title
Special Drug Use Investigation in patients with critical lower limb ischemia under conservative treatment
Scientific Title:Acronym
Special Drug Use Investigation in patients with critical lower limb ischemia under conservative treatment
Region
| Japan |
Condition
Condition
Chronic arterial occlusive disease (arteriosclerosis obliterans or Buerger's disease)
Classification by specialty
| Cardiology | Vascular surgery | Dermatology |
| Plastic surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Patients with critical limb ischemia due to chronic arterial occlusion (arteriosclerosis obliterans or Buerger's disease) under conservative treatment who have inadequate response to standard drug therapy and difficulty in undergoing revascularization shall be prospectively registered to collect medical data for "Special Drug Use Investigation in patients with critical lower limb ischemia under conservative treatment". Data from this investigation shall be used as control group of "Special Drug Use Investigation of Collategene with long-term observation", which will be conducted as a drug use comparative investigation for post-marketing evaluation of approval conditions of Collategene.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Rate of complete ulcer healing at Week 12
Key secondary outcomes
- Change in ulcer size at Week 12
- Total number of ulcers and summation of ulcers in the index limb at Week 12
- Change in hemodynamic parameters in the index limb at Week 12
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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) Patients aged =>20 years
2) Patients with ischemia due to hematogenous disorder confirmed with objective measures in the target limb
3) Patients with clinical symptoms of ulcers caused by lower limb ischemia due to lower limb arterial occlusion or stenosis in the target limb
4) Patients in whom ulcer size in the target limb can be measured
5) Patients who have inadequate response to standard drug therapy and difficulty in undergoing revascularization for the target limb
Key exclusion criteria
1) Patients with ulcers that expose bone or tendon, or gangrene, in the target or contralateral limb
2) Patients with extensive necrotic tissue or a life-threatening infection uncontrolled by antibiotics in the lower limb
3) Patients with current evidence or a history of malignant neoplasm in the target limb
4) Patients who underwent revascularization of the target limb within 4 weeks prior to registration However, this shall not apply if ischemia persists or is confirmed by an objective measure.
5) Patients with ischemic symptoms due to acute arterial occlusion in the target limb within 4 weeks prior to registration
6) Patients who are scheduled to undergo revascularization of the target limb within 12 weeks after registration
7) Patients who received Collategene
8) Patients who received angiogenic therapy other than Collategene or vascular regeneration therapy within 6 months prior to registration
9) Patients who previously participated in the investigation as a control patient
10) Other patients who, in the opinion of the investigator, are ineligible for the investigation
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Mitsuaki |
| Middle name | Chujo |
| Last name | Chujo |
Organization
AnGes, Inc.
Division name
Pharmacovigilance Department
Zip code
108-0014
Address
4-13-3, Shiba, Minato-ku, Tokyo 108-0014 Japan
TEL
+81-3-5730-2817
mchujo@anges.co.jp
Public contact
Name of contact person
| 1st name | Mitsuaki |
| Middle name | Chujo |
| Last name | Chujo |
Organization
AnGes, Inc.
Division name
Pharmacovigilance Department
Zip code
108-0014
Address
4-13-3, Shiba, Minato-ku, Tokyo 108-0014 Japan
TEL
+81-3-5730-2817
Homepage URL
mchujo@anges.co.jp
Sponsor or person
Institute
AnGes, Inc.
Institute
Department
Personal name
Funding Source
Organization
AnGes, Inc.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Not applicable due to Special Drug Use Investigation
Address
-
Tel
-
-
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
| 2021 | Year | 07 | 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
82
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
| 2019 | Year | 08 | Month | 14 | Day |
Date of IRB
| 2019 | Year | 08 | Month | 14 | Day |
Anticipated trial start date
| 2019 | Year | 09 | Month | 10 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
nothing special
Management information
Registered date
| 2021 | Year | 07 | Month | 27 | Day |
Last modified on
| 2023 | Year | 12 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047434
