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OTR4120: topical application at venous ulcers. A clinical evaluation of cicatrisation.

Conditions
ulcervenouschronic
Registration Number
NL-OMON21990
Brief Summary

/A

Detailed Description

Not available

Recruitment & Eligibility

Status
Pending
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
NameTimeMethod
Clinical improvement of the investigated ulcers, measured as the reduction of the wound area in time.
Secondary Outcome Measures
NameTimeMethod
- Complete healing of the ulcer (measured as the time to complete healing). <br /><br><br /><br>- Improvement of the pain status without the use of analgetica.<br /><br><br /><br>- Reduction of the total score in the PUSH tool.<br /><br><br /><br>- Safety of the experimental treatment.<br>
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