UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035333 |
|---|---|
| Receipt number | R000040254 |
| Scientific Title | Clinical study of the effect of disposable warmer on Vasodilatation/Angiogenesis for the patients with Upper limb Circulation disorder |
| Date of disclosure of the study information | 2018/12/21 |
| Last modified on | 2024/01/19 19:20:45 |
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Basic information
Public title
Clinical study of the effect of disposable warmer on Vasodilatation/Angiogenesis for the patients with Upper limb Circulation disorder
Acronym
VANG-UCir
Scientific Title
Clinical study of the effect of disposable warmer on Vasodilatation/Angiogenesis for the patients with Upper limb Circulation disorder
Scientific Title:Acronym
VANG-UCir
Region
| Japan |
Condition
Condition
Systemic Sclerosis
Classification by specialty
| Medicine in general |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
For patients with systemic sclerosis showing Raynaud's phenomenon, it is examined whether warming the cervix, elbow or hand joint with a warmer to see if the effect on the vasodilator and angiogenic factors in the periphery of the fingers appears .
Basic objectives2
Others
Basic objectives -Others
To explore the induction by the heat stimulation.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Serum concentration of angiopoietin-1
Key secondary outcomes
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Out-patients of Osaka University Hospital
Patients who are participating the Clinical study of Usability and Safety under the use of disposable warmer on each site for the patients with Upper limb Circulation disorder (US-UCir).
Key exclusion criteria
1. Patients who conflict with exclusion criteria of the Clinical study of Usability and Safety under the use of disposable warmer on each site for the patients with Upper limb Circulation disorder (US-UCir).
2. Patients who have difficulty drawing blood from the elbow vein by curing limbs.
3. Patients with skin ulcer at the apex of the finger.
4. Patients judged by the researcher as inappropriate.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Yoshihito |
| Middle name | |
| Last name | Shima |
Organization
Osaka University Graduate School of Medicine
Division name
Laboratory of Thermo-therapeutics for Vascular dysfunction
Zip code
5650871
Address
1-3 Yamada-oka, Suita city, 565-0871 Osaka, Japan
TEL
06(6105)5710
ryanjin@imed3.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | Akane |
| Middle name | |
| Last name | Watanabe |
Organization
Osaka University Graduate School of Medicine
Division name
Laboratory of Thermo-therapeutics for Vascular dysfunction
Zip code
5650871
Address
1-3 Yamada-oka, Suita city, 565-0871 Osaka, Japan
TEL
06(6105)5710
Homepage URL
a.watanabe@imed3.med.osaka-u.ac.jp
Sponsor or person
Institute
Osaka University
Institute
Department
Personal name
Funding Source
Organization
Joint research project of Osaka University with Kiribai Chemical Co.,Ltd. and Kobayashi Pharmaceutical Co.,Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
JP
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethical committee of Osaka University Hospital
Address
2-2 Yamada-oka, Suita city, 565-0871 Osaka, Japan
Tel
0668795111
rinri@hp-crc.med.osaka-u.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
| 2018 | Year | 12 | Month | 21 | Day |
Related information
URL releasing protocol
https://academic.oup.com/mr/article/32/2/351/6363900?login=true
Publication of results
Published
Result
URL related to results and publications
https://academic.oup.com/mr/article/32/2/351/6363900?login=true
Number of participants that the trial has enrolled
15
Results
In cubital vein blood samples, no changes were observed in the average angiopoietin-1, angiopoietin-2, VEGF, and endostatin concentrations before and after warming the neck, both elbows, and both wrists.
In the fingertip blood samples, angiopoietin-1 concentration increased after warming any sites, and endostatin concentration increased after wrist warming. Angiopoietin-2 and VEGF were not detected in fingertip blood samples.
Results date posted
| 2024 | Year | 01 | Month | 19 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The average age of 14 cases was 60 years old. The average disease period was 13 years. There were 10 women and 4 male cases. There were seven cases of diffuse cutaneous SSc, and seven cases of limited cutaneous SSc. There were seven prednisolone users, and the average dose was 7.38 mg/day. There were three beraprost users, and their average dose was 120microg/day. There were three bosentan users, and their average dose was 125 mg/day.
Participant flow
Sixteen SSc patients were enrolled in this study. One patient withdrew the consent, and one patient was not eligible. Fourteen participants finished all processes of this study.
Adverse events
There were five events of a minor burn; three occurred after the neck heating and the remaining two occurred after the elbow heating. All of them were epidermal and were cured. Eczema, probably due to increased sweating, was observed in one patient after neck heating. Two patients showed fingertip changes (epidermal peeling and laceration) during the interval period. One patient experienced parotid swelling during the pre-treatment observation period.
Outcome measures
Angiopoietin-1, a capillary stabilizing factor, was increased by heating the neck, elbow, and wrist in the fingertips of SSc patients whose peripheral capillaries are damaged. It is expected that heating these areas will reduce capillary damage of SSc patients' hands. In the UMINAAA study, warming of the neck and elbows was effective in improving Raynaud's phenomenon, and warming of the wrists was not effective. It is speculated that this may be related to the increase in endostatin, a capillary inhibitory factor, observed in this study after warming the wrist.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2018 | Year | 12 | Month | 12 | Day |
Date of IRB
| 2018 | Year | 11 | Month | 29 | Day |
Anticipated trial start date
| 2019 | Year | 01 | Month | 11 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Serum angiopoietin-1 and eNOS concentrarion are going to measure.
Management information
Registered date
| 2018 | Year | 12 | Month | 21 | Day |
Last modified on
| 2024 | Year | 01 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040254
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