OTR4120: topical application at diabetic ulcers. A clinical evaluation of cicatrisation.
Recruiting
- Conditions
- Diabetic ulcer, Chronic ulcer
- Registration Number
- NL-OMON25496
- Lead Sponsor
- Erasmus Medical Center, Department of Plastic Surgery, Department of Dermatology
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 100
Inclusion Criteria
1. Signed informed consent.
2. Age at least 18 years.
Exclusion Criteria
1. Minor aged patients.
2. Pregnant or breast-feeding women.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Clinical improvement of the investigated ulcers, measured as the reduction of the wound area in time.
- Secondary Outcome Measures
Name Time Method 1. Complete healing of the ulcer (measured as the time to complete healing). <br /><br>2. Improvement of the pain status without the use of analgetica.<br /><br>3. Reduction of the total score in the PUSH tool.