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

NCT02642146 | Terminated

• 1 other identifier: SNUH-IMJ-002
• Study Type: observational
• Target: 71
• Locations: 1 country
• Sites: 1

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.

Conditions

Raynaud Disease; Systemic Sclerosis; Digital Ulcer

Outcome Measures

Primary Outcomes (1)

• Time to resolution of cardinal DU

  weeks or days (from baseline)

Secondary Outcomes (5)

• 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 Outcomes (2)

• Number of patients requiring amputation

  weeks 4, 8, 12, 24

• Number of adverse events

  weeks 4, 8, 12, 24

Interventions

Calcium Channel Blockers DRUG

Phosphodiesterase Inhibitors DRUG

Endothelin receptor blocker DRUG

Prostanoids DRUG

Other vasodilator DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with systemic sclerosis

You may qualify if:

• Age of 18 years or older
• SSc diagnosis according to 1980 or 2013 ACR classification criteria
• or more active DU
• Patients who start or change medical treatment for DU
• Patients who are willing to participate

You may not qualify if:

• Pregnancy or active breast feeding
• Patients with life expectancy \< 6 months

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Hospital

Seoul, 110-744, South Korea

Location

MeSH Terms

Conditions

Raynaud Disease; Scleroderma, Systemic; digital ulcers

Interventions

Calcium Channel Blockers; Phosphodiesterase Inhibitors; Prostaglandins

Condition Hierarchy (Ancestors)

Livedoid Vasculopathy; Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Skin Diseases, Vascular; Skin Diseases; Skin and Connective Tissue Diseases; Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Membrane Transport Modulators; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Calcium-Regulating Hormones and Agents; Physiological Effects of Drugs; Cardiovascular Agents; Therapeutic Uses; Enzyme Inhibitors; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor/M.D, PhD

Study Record Dates

• First Submitted: December 24, 2015
• First Posted: December 30, 2015
• Study Start: January 1, 2015
• Primary Completion: June 1, 2019
• Study Completion: June 1, 2019
• Last Updated: November 10, 2020

Record last verified: 2020-11

Locations

KR (1)