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

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

Study Overview

• Status: Terminated
• Conditions: Systemic Sclerosis; Raynaud Disease; Digital Ulcer
• Intervention / Treatment: Drug: Calcium Channel Blockers; Drug: Phosphodiesterase Inhibitors; Drug: Endothelin receptor blocker; Drug: Prostanoids; Drug: Other vasodilator

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

• Study Type: Observational
• Enrollment (Actual): 71

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 110-744
    • Seoul National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with systemic sclerosis

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Time to resolution of cardinal DU	weeks or days (from baseline)

Secondary Outcome Measures

Outcome Measure	Time Frame
Change in size of cardinal DU from baseline	weeks 4, 8, 12, 24 weeks
Change in DU number from baseline	weeks 4, 8, 12, 24
Number of new DU	weeks 4, 8, 12, 24
Case of successful digital ulcer treatment with tolerable side	weeks 4, 8, 12, 24
Number of patients with superinfection	weeks 4, 8, 12, 24

Other Outcome Measures

Outcome Measure	Time Frame
Number of patients requiring amputation	weeks 4, 8, 12, 24
Number of adverse events	weeks 4, 8, 12, 24

Collaborators and Investigators

• Sponsor: Seoul National University Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2015
• Primary Completion (ACTUAL): June 1, 2019
• Study Completion (ACTUAL): June 1, 2019

Study Registration Dates

• First Submitted: December 24, 2015
• First Submitted That Met QC Criteria: December 29, 2015
• First Posted (ESTIMATE): December 30, 2015

Study Record Updates

• Last Update Posted (ACTUAL): November 10, 2020
• Last Update Submitted That Met QC Criteria: November 8, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Skin Diseases; Connective Tissue Diseases; Peripheral Vascular Diseases; Sclerosis; Scleroderma, Systemic; Scleroderma, Diffuse; Raynaud Disease; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Membrane Transport Modulators; Calcium-Regulating Hormones and Agents; Calcium; Calcium Channel Blockers; Vasodilator Agents; Phosphodiesterase Inhibitors
• Other Study ID Numbers: SNUH-IMJ-002