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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
  Purpose
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.

Condition Intervention Phase
Ulcus Cruris Drug: octenisept® Drug: Placebo Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Randomized, Double-blind, Single-center, Placebo-controlled Study to Evaluate the Efficacy of Octenisept® in Patients With Chronic Wounds

Resource links provided by NLM:


Further study details as provided by Schülke & Mayr GmbH:

Primary Outcome Measures:
  • Antimicrobial efficacy of octenisept® compared to placebo [ Time Frame: 2 weeks after baseline ]
    Decrease of bacterial load after 2 weeks of treatment


Secondary Outcome Measures:
  • 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)


Enrollment: 9
Study Start Date: October 2011
Study Completion Date: July 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: verum Drug: octenisept®
Cutaneous solution
Placebo Comparator: Placebo Drug: Placebo
Cutaneous use

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 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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01434914


Locations
Germany
University Medical Center Hamburg-Eppendorf
Hamburg, Germany
Sponsors and Collaborators
Schülke & Mayr GmbH
Investigators
Principal Investigator: Matthias Augustin, MD Universitätsklinikum Hamburg-Eppendorf
  More Information

Additional Information:
Publications:
Vanscheidt W, Baer M, May TW, Siebert J.: Affecting the wound healing process of chronic ulcera by an octenidine based wound antiseptic. Hyg Med (2005) 30 (5): 153-8

Responsible Party: Schülke & Mayr GmbH
ClinicalTrials.gov Identifier: NCT01434914     History of Changes
Other Study ID Numbers: OCT-UKE-2011
First Submitted: September 13, 2011
First Posted: September 15, 2011
Last Update Posted: May 13, 2014
Last Verified: May 2014

Keywords provided by Schülke & Mayr GmbH:
Ulcus cruris
chronic wounds
octenisept®

Additional relevant MeSH terms:
Foot Ulcer
Foot Diseases
Skin Diseases
Leg Ulcer
Skin Ulcer
Octenidine
Anti-Infective Agents
Anti-Infective Agents, Local