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Treatment of Digital Ulcers in Korean Patients With Systemic Sclerosis: a Prospective Cohort Study

Status
Terminated
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02642146
Enrollment
71
Registered
2015-12-30
Start date
2015-01-31
Completion date
2019-06-30
Last updated
2020-11-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Raynaud Disease, Systemic Sclerosis, Digital Ulcer

Brief summary

This study evaluates the efficacy and safety of routine medical treatments of digital ulcers in patients with systemic sclerosis in a prospective cohort study.

Detailed description

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 1. To establish a new prospective cohort of SSc patients with DU in Korea.. 2. To investigate the current situation of SSc patients in Korea. 3. To investigate and compare the efficacy and safety of current medical treatments of DU in SSc patients in Korea

Interventions

DRUGPhosphodiesterase Inhibitors
DRUGEndothelin receptor blocker
DRUGProstanoids
DRUGOther vasodilator

Sponsors

Seoul National University Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Time to resolution of cardinal DUweeks or days (from baseline)

Secondary

MeasureTime frame
Change in size of cardinal DU from baselineweeks 4, 8, 12, 24 weeks
Change in DU number from baselineweeks 4, 8, 12, 24
Number of new DUweeks 4, 8, 12, 24
Case of successful digital ulcer treatment with tolerable sideweeks 4, 8, 12, 24
Number of patients with superinfectionweeks 4, 8, 12, 24

Other

MeasureTime frame
Number of patients requiring amputationweeks 4, 8, 12, 24
Number of adverse eventsweeks 4, 8, 12, 24

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026