A prospective study for connective tissue disease related digital ulcer in Korea
- Conditions
- Diseases of the musculo-skeletal system and connective tissue
- Registration Number
- KCT0004859
- Lead Sponsor
- Soon Chun Hyang University Hospital Seoul
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 35
adult patients with systemic slerosis(SSc) or mixed connective tissue disease(MCTD) with active digital ulcers, with or without pulmonary arterial hypertension (PAH), in the last 6 months, from the rheumatology department of the 4 institutions
All patients fulfilled the 2013 American College of Rheumatology/EULAR classification criteria or the MCTD criteria according to Sharp et al.
Patients were excluded if they had taken phosphodiesterase type 5 (PDE-5) inhibitors or other endothelin receptor antagonists within 1 month and had used prostacyclin analogues within the previous 3 months 4. The concurrent use of aspirin, calcium channel blocker (CCB), angiotensin-converting enzyme inhibitor (ACEi), and angiotensin II receptor blocker (ARB) was acceptable at the same dose as the last 4 weeks before study enrollment.
Study & Design
- Study Type
- Observational Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The numbers of healed and new DUs and the largest diameter of DUs were assessed at baseline and at 4, 8, 16, and 24 weeks after treatment with bosentan
- Secondary Outcome Measures
Name Time Method nailfold capillaroscopy was performed using a light microscope (SZ-PT; Olympus, Tokyo, Japan) with 200x magnification