Trial | NCT01434914  Report issue

Title

Study to Evaluate the Efficacy of Octenisept® in Patients With Chronic Wounds
Randomized, Double-blind, Single-center, Placebo-controlled Study to Evaluate the Efficacy of Octenisept® in Patients With Chronic Wounds

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Terminated

  • Study Participants

    9
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. Patients will be randomized to either the octenisept® group or to the placebo group.
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 will be randomized to either the octenisept® group or to the placebo group.

Primary Objectives: Antimicrobial efficacy of octenisept® compared to placebo. Secondary Objectives: Subjective tolerance of octenisept®, evaluation of wound parameters.
Study Started
Oct 31
2011
Primary Completion
Jul 31
2013
Study Completion
Jul 31
2013
Last Update
May 13
2014
Estimate

Drug octenisept®

Cutaneous solution

Drug Placebo

Cutaneous use

verum Active Comparator

Placebo Placebo Comparator

Criteria 

Inclusion Criteria:

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 Criteria:

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
No Results Posted