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

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ClinicalTrials.gov Identifier: NCT02642146
Recruitment Status : Terminated (We decided to terminate recruit earlier because patient recruiting was not active as expected at the beginning of the study.)
First Posted : December 30, 2015
Last Update Posted : November 10, 2020
Sponsor:
Information provided by (Responsible Party):
Eun Bong Lee, Seoul National University Hospital

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.

Condition or disease Intervention/treatment
Raynaud Disease Systemic Sclerosis Digital Ulcer 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

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Study Type : Observational [Patient Registry]
Actual Enrollment : 71 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 3 Years
Actual Study Start Date : January 2015
Actual Primary Completion Date : June 2019
Actual Study Completion Date : June 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Scleroderma




Primary Outcome Measures :
  1. Time to resolution of cardinal DU [ Time Frame: weeks or days (from baseline) ]

Secondary Outcome Measures :
  1. Change in size of cardinal DU from baseline [ Time Frame: weeks 4, 8, 12, 24 weeks ]
  2. Change in DU number from baseline [ Time Frame: weeks 4, 8, 12, 24 ]
  3. Number of new DU [ Time Frame: weeks 4, 8, 12, 24 ]
  4. Case of successful digital ulcer treatment with tolerable side [ Time Frame: weeks 4, 8, 12, 24 ]
  5. Number of patients with superinfection [ Time Frame: weeks 4, 8, 12, 24 ]

Other Outcome Measures:
  1. Number of patients requiring amputation [ Time Frame: weeks 4, 8, 12, 24 ]
  2. Number of adverse events [ Time Frame: weeks 4, 8, 12, 24 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with systemic sclerosis
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02642146


Locations
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Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of, 110-744
Sponsors and Collaborators
Seoul National University Hospital
Additional Information:

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Responsible Party: Eun Bong Lee, Professor/M.D, PhD, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT02642146    
Other Study ID Numbers: SNUH-IMJ-002
First Posted: December 30, 2015    Key Record Dates
Last Update Posted: November 10, 2020
Last Verified: November 2020
Additional relevant MeSH terms:
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Raynaud Disease
Scleroderma, Systemic
Scleroderma, Diffuse
Sclerosis
Pathologic Processes
Connective Tissue Diseases
Skin Diseases
Peripheral Vascular Diseases
Vascular Diseases
Cardiovascular Diseases
Calcium Channel Blockers
Vasodilator Agents
Calcium
Phosphodiesterase Inhibitors
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors