Prospective randomized controlled double-blind multicentric phase III study to evaluate antiseptic efficacy and local tolerability of Stellisept mucosa in patients with chronic wounds
- Conditions
- ulcus cruris
- Registration Number
- EUCTR2006-000061-11-DE
- Lead Sponsor
- BODE Chemie GmbH & Co
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 60
Inclusion Criteria
male and female
18-80 years
use of contraceptives if applicable
no pregnancy
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
age below 18 or over 80
pregnant women /nursing mother
severe accompanying disease
known allergy to the drug or one of its ingredients
missing informed consent
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: demonstrate antiseptic efficacy of product;Secondary Objective: demonstrate local tolerability of product;Primary end point(s): antiseptic efficacy (reduction of baterial load
- Secondary Outcome Measures
Name Time Method