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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02642146 |
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Date of registration:
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24/12/2015 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Treatment of Digital Ulcers in Korean Patients With Systemic Sclerosis: a Prospective Cohort Study
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Scientific title:
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Date of first enrolment:
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January 2015 |
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Target sample size:
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71 |
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Recruitment status: |
Terminated |
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URL:
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https://clinicaltrials.gov/show/NCT02642146 |
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Study type:
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Observational [Patient Registry] |
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Study design:
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Phase:
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Countries of recruitment
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Korea, Republic of
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Age of 18 years or older
- SSc diagnosis according to 1980 or 2013 ACR classification criteria
- 1 or more active DU
- Patients who start or change medical treatment for DU
- Patients who are willing to participate
Exclusion Criteria:
- Pregnancy or active breast feeding
- Patients with life expectancy < 6 months
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Systemic Sclerosis
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Digital Ulcer
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Raynaud Disease
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Intervention(s)
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Drug: Prostanoids
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Drug: Calcium Channel Blockers
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Drug: Endothelin receptor blocker
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Drug: Other vasodilator
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Drug: Phosphodiesterase Inhibitors
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Primary Outcome(s)
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Time to resolution of cardinal DU
[Time Frame: weeks or days (from baseline)]
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Secondary Outcome(s)
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Change in size of cardinal DU from baseline
[Time Frame: weeks 4, 8, 12, 24 weeks]
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Number of patients with superinfection
[Time Frame: weeks 4, 8, 12, 24]
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Number of new DU
[Time Frame: weeks 4, 8, 12, 24]
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Case of successful digital ulcer treatment with tolerable side
[Time Frame: weeks 4, 8, 12, 24]
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Change in DU number from baseline
[Time Frame: weeks 4, 8, 12, 24]
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Secondary ID(s)
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SNUH-IMJ-002
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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