A phase 2 study of SR-0379 in patients with cutaneous ulcer (pressure ulcer, diabetic ulcer)
Phase 2
Completed
- Conditions
- Cutaneous ulcer (pressure ulcer, diabetic ulcer)
- Registration Number
- JPRN-jRCT2080223939
- Lead Sponsor
- Shionogi & Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 120
Inclusion Criteria
Patients whose major axis of ulcer is 1 cm or more and 6 cm or less, and depth of ulcer is classified into d2, D3, or D4 referring to the DESIGN-R(R) for evaluation of pressure ulcer (Japanese Society of Pressure Ulcers), etc.
Exclusion Criteria
Patients who have ulcer with apparent infection including flare, swelling, pus, malodor, or fever around the ulcer, etc.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method efficacy<br>The percent reduction in surface area of the ulcer
- Secondary Outcome Measures
Name Time Method safety<br>Percentage of patients with any adverse events, etc.