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

Systemic Sclerosis Clinical Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02642146
• Other study ID #: SNUH-IMJ-002
• Status: Terminated
• Start date: January 2015
• Est. completion date: June 2019

Study information

• Verified date: November 2020
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 71
• Est. completion date: June 2019
• Est. primary completion date: June 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Digital Ulcer
• Raynaud Disease
• Scleroderma, Diffuse
• Scleroderma, Systemic
• Sclerosis
• Systemic Sclerosis

Intervention

Drug:
• Calcium Channel Blockers

• Phosphodiesterase Inhibitors

• Endothelin receptor blocker

• Prostanoids

• Other vasodilator

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of patients requiring amputation		weeks 4, 8, 12, 24
Other	Number of adverse events		weeks 4, 8, 12, 24
Primary	Time to resolution of cardinal DU		weeks or days (from baseline)
Secondary	Change in size of cardinal DU from baseline		weeks 4, 8, 12, 24 weeks
Secondary	Change in DU number from baseline		weeks 4, 8, 12, 24
Secondary	Number of new DU		weeks 4, 8, 12, 24
Secondary	Case of successful digital ulcer treatment with tolerable side		weeks 4, 8, 12, 24
Secondary	Number of patients with superinfection		weeks 4, 8, 12, 24