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

NCT ID: NCT02642146

Last Updated: 2020-11-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

71 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-01-31

Study Completion Date

2019-06-30

Brief Summary

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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

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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

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Raynaud Disease Systemic Sclerosis Digital Ulcer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Calcium Channel Blockers

Intervention Type DRUG

Phosphodiesterase Inhibitors

Intervention Type DRUG

Endothelin receptor blocker

Intervention Type DRUG

Prostanoids

Intervention Type DRUG

Other vasodilator

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Eun Bong Lee

Professor/M.D, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Seoul National University Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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SNUH-IMJ-002

Identifier Type: -

Identifier Source: org_study_id