Raynaud DiseaseNCT02642146
Treatment of Digital Ulcers in Korean Patients With Systemic Sclerosis: a Prospective Cohort Study
An observational study of Raynaud Disease and Systemic Sclerosis, run by Seoul National University Hospital at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Raynaud Disease, Systemic Sclerosis, Digital Ulcer
- What is being tested?
- Calcium Channel Blockers, Phosphodiesterase Inhibitors and Endothelin receptor blocker
- How many people
- 71 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jan 2015to Jun 2019
- How long will I take part?
- 3 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with systemic sclerosis
Who may be able to join
- 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
Who cannot join
- Pregnancy or active breast feeding
- Patients with life expectancy < 6 months
Trial locations and contacts
1 site in 1 country.
About this 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.
Read the 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
- To establish a new prospective cohort of SSc patients with DU in Korea..
- To investigate the current situation of SSc patients in Korea.
- To investigate and compare the efficacy and safety of current medical treatments of DU in SSc patients in Korea
- Conditions
- Raynaud Disease, Systemic Sclerosis, Digital Ulcer
- Being tested
- Calcium Channel Blockers, Phosphodiesterase Inhibitors, Endothelin receptor blocker, Prostanoids, Other vasodilator
- Medical subject headings
- Raynaud Disease, Scleroderma, Systemic, digital ulcers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Calcium Channel BlockersDrug
Phosphodiesterase InhibitorsDrug
Endothelin receptor blockerDrug
ProstanoidsDrug
Other vasodilatorDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to resolution of cardinal DU
Measured: weeks or days (from baseline)
Secondary outcomes (5)
Change in size of cardinal DU from baseline
Measured: weeks 4, 8, 12, 24 weeks
Change in DU number from baseline
Measured: weeks 4, 8, 12, 24
Number of new DU
Measured: weeks 4, 8, 12, 24
Case of successful digital ulcer treatment with tolerable side
Measured: weeks 4, 8, 12, 24
Number of patients with superinfection
Measured: weeks 4, 8, 12, 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2015 (estimated)
- Study startJan 2015
- Primary completionJun 2019
- Study completionJun 2019
Why it stopped: We decided to terminate recruit earlier because patient recruiting was not active as expected at the beginning of the study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Raynaud DiseaseStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 71 participants (actual)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eun Bong Lee, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02642146
- Sponsor's protocol ID
- SNUH-IMJ-002
- Status last verified
- Nov 2020
- First submitted
- 24 Dec 2015
- Last updated
- 10 Nov 2020
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Digital Ulcers in Korean Patients With Systemic Sclerosis: a Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT02642146
- Acronym / sponsor ID
- SNUH-IMJ-002
- Conditions
- Raynaud Disease, Systemic Sclerosis, Digital Ulcer
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: We decided to terminate recruit earlier because patient recruiting was not active as expected at the beginning of the study.
- Enrolment
- 71 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Jan 2015 (actual)
- Primary completion
- Jun 2019 (actual)
- Study completion
- Jun 2019 (actual)
- First posted
- 30 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- To establish a new prospective cohort of SSc patients with DU in Korea..
- To investigate the current situation of SSc patients in Korea.
- To investigate and compare the efficacy and safety of current medical treatments of DU in SSc patients in Korea
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with systemic sclerosis
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- Pregnancy or active breast feeding
- Patients with life expectancy < 6 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Calcium Channel Blockers | Drug | – |
| Phosphodiesterase Inhibitors | Drug | – |
| Endothelin receptor blocker | Drug | – |
| Prostanoids | Drug | – |
| Other vasodilator | Drug | – |
Primary outcome
Time to resolution of cardinal DU
Time frame: weeks or days (from baseline)
5 secondary outcomes
Change in size of cardinal DU from baseline
Time frame: weeks 4, 8, 12, 24 weeks
Change in DU number from baseline
Time frame: weeks 4, 8, 12, 24
Number of new DU
Time frame: weeks 4, 8, 12, 24
Case of successful digital ulcer treatment with tolerable side
Time frame: weeks 4, 8, 12, 24
Number of patients with superinfection
Time frame: weeks 4, 8, 12, 24
Results and safety
The study was stopped early (reason given: We decided to terminate recruit earlier because patient recruiting was not active as expected at the beginning of the study.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Raynaud Disease and Systemic Sclerosis, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 10 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: We decided to terminate recruit earlier because patient recruiting was not active as expected at the beginning of the study.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to resolution of cardinal DU (time frame: weeks or days (from baseline)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Nov 2020.