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Study to Evaluate the Efficacy of Octenisept® in Patients With Chronic Wounds

This study has been terminated.
(early termination due to poor recruitment)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01434914
First Posted: September 15, 2011
Last Update Posted: May 13, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Schülke & Mayr GmbH
September 13, 2011
September 15, 2011
May 13, 2014
October 2011
July 2013   (Final data collection date for primary outcome measure)
Antimicrobial efficacy of octenisept® compared to placebo [ Time Frame: 2 weeks after baseline ]
Decrease of bacterial load after 2 weeks of treatment
Same as current
Complete list of historical versions of study NCT01434914 on ClinicalTrials.gov Archive Site
  • Subjective tolerance of octenisept® [ Time Frame: 2 weeks after baseline ]
    Clinical signs of tolerance of octenisept®
  • Evaluation of wound parameters [ Time Frame: 2 weeks after baseline ]
    Evaluation of wound healing time and wound size (Planimetry)
Same as current
Not Provided
Not Provided
 
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
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.

Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Ulcus Cruris
  • Drug: octenisept®
    Cutaneous solution
  • Drug: Placebo
    Cutaneous use
  • Active Comparator: verum
    Intervention: Drug: octenisept®
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
9
July 2013
July 2013   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
 
NCT01434914
OCT-UKE-2011
No
Not Provided
Not Provided
Schülke & Mayr GmbH
Schülke & Mayr GmbH
Not Provided
Principal Investigator: Matthias Augustin, MD Universitätsklinikum Hamburg-Eppendorf
Schülke & Mayr GmbH
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP
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