Treatment of Digital Ulcers in Korean Patients With Systemic Sclerosis: a Prospective Cohort Study
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|ClinicalTrials.gov Identifier: NCT02642146|
Recruitment Status : Terminated (We decided to terminate recruit earlier because patient recruiting was not active as expected at the beginning of the study.)
First Posted : December 30, 2015
Last Update Posted : November 10, 2020
|Condition or disease||Intervention/treatment|
|Raynaud Disease Systemic Sclerosis Digital Ulcer||Drug: Calcium Channel Blockers Drug: Phosphodiesterase Inhibitors Drug: Endothelin receptor blocker Drug: Prostanoids Drug: Other vasodilator|
Systemic sclerosis (SSc) is a chronic autoimmune disease of unknown etiology with high morbidity and mortality. SSc manifests by fibrosis of skin and internal organs. Although the underlying mechanisms are still subject to investigation, endothelial dysfunction and abnormal immune response are thought to contribute to vascular dysfunction and fibrosis in SSc.
A hallmark feature of SSc is the presence of Raynaud phenomenon (RP) that is caused by reversible vasoconstriction of digital arteries triggered by exposure to cold or emotional stress. In up to 33-43% of SSc patients, the ischemia can progress to digital ulcers (DUs), which are often associated not only with pain but also with severe limitation in the daily activity, anxiety and depression among others. In severe cases, RP can be complicated by superinfection or gangrene, requiring surgical amputation.
The mainstay treatment of RP is restoration of the decreased blood flow using calcium channel blocker, protstanoids, phosphodiesterse V inhibitor, and endothelin receptor blocker. However, the efficacy and safety of those medications in RP-associated ulcers have not been definitive, especially in Korean patients with SSc. In addition, it remains unknown whether Korean SSc patients respond better to a treatment over others.
Study aims include
- To establish a new prospective cohort of SSc patients with DU in Korea..
- To investigate the current situation of SSc patients in Korea.
- To investigate and compare the efficacy and safety of current medical treatments of DU in SSc patients in Korea
|Study Type :||Observational [Patient Registry]|
|Actual Enrollment :||71 participants|
|Target Follow-Up Duration:||3 Years|
|Actual Study Start Date :||January 2015|
|Actual Primary Completion Date :||June 2019|
|Actual Study Completion Date :||June 2019|
- Time to resolution of cardinal DU [ Time Frame: weeks or days (from baseline) ]
- Change in size of cardinal DU from baseline [ Time Frame: weeks 4, 8, 12, 24 weeks ]
- Change in DU number from baseline [ Time Frame: weeks 4, 8, 12, 24 ]
- Number of new DU [ Time Frame: weeks 4, 8, 12, 24 ]
- Case of successful digital ulcer treatment with tolerable side [ Time Frame: weeks 4, 8, 12, 24 ]
- Number of patients with superinfection [ Time Frame: weeks 4, 8, 12, 24 ]
- Number of patients requiring amputation [ Time Frame: weeks 4, 8, 12, 24 ]
- Number of adverse events [ Time Frame: weeks 4, 8, 12, 24 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02642146
|Korea, Republic of|
|Seoul National University Hospital|
|Seoul, Korea, Republic of, 110-744|