Status:
TERMINATED
Study to Evaluate the Efficacy of Octenisept® in Patients With Chronic Wounds
Lead Sponsor:
Schülke & Mayr GmbH
Conditions:
Ulcus Cruris
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
This is a randomized, double-blind, placebo-controlled trial with octenisept® or placebo in patients with chronic leg ulcers. The study will be conducted at a single center with a total of 70 patients...
Detailed Description
Randomized, double-blind, placebo-controlled trial with octenisept® or placebo in patients with chronic leg ulcers. The study will be conducted at a single center with a total of 70 patients. Patients...
Eligibility Criteria
Inclusion
- Male and female patients of at least 18 years at the time of consent
- Patients with a venous leg ulcer (Ulcus cruris)
- Patients with a chronic leg ulcer
- Females of childbearing potential who are willing to comply with any applicable contraceptive requirements of the protocol
- Negative pregnancy test
- Satisfactory medical assessment
- Ability to provide written informed consent
- Signed declaration of consent
- Willingness to co-operate
Exclusion
- Pregnant or lactating women and women not using contraception
- Known history of alcohol or drug abuse
- Use of any antibiotic medication within the last 7 days prior to the first dose
- Patients with serious concomitant disease
- Patients with a coagulation disorder
- Known history of allergic reactions attributed to octenisept® or one of its compounds
- Participation in another clinical trial within the last 30 days before randomization
- Concomitant treatment with other preparations that interfere with the trial preparation or the disease
- Absence of declaration of consent
- Doubt about willingness to co-operate
- Non-fulfilment of the inclusion criteria
Key Trial Info
Start Date :
October 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2013
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT01434914
Start Date
October 1 2011
End Date
July 1 2013
Last Update
May 13 2014
Active Locations (1)
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1
University Medical Center Hamburg-Eppendorf
Hamburg, Germany