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

Seoul National University

Status

Terminated

Conditions

Systemic Sclerosis

Raynaud Disease

Digital Ulcer

Treatments

Drug: Prostanoids

Drug: Phosphodiesterase Inhibitors

Drug: Calcium Channel Blockers

Drug: Endothelin receptor blocker

Drug: Other vasodilator

Study type

Observational

Funder types

Other

Identifiers

NCT02642146

SNUH-IMJ-002

Details and patient eligibility

About

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

Full 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

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

Enrollment

71 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria