NCT02642146

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

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 71 (actual)
• Sponsor: Seoul National University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Raynaud Disease
• Systemic Sclerosis
• Digital Ulcer

Interventions

Type	Name	Description
DRUG	Calcium Channel Blockers
DRUG	Phosphodiesterase Inhibitors
DRUG	Endothelin receptor blocker
DRUG	Prostanoids
DRUG	Other vasodilator

Timeline

• Start date: 2015-01-01
• Primary completion: 2019-06-01
• Completion: 2019-06-01
• First posted: 2015-12-30
• Last updated: 2020-11-10

Locations

1 site across 1 country: South Korea