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

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ClinicalTrials.gov Identifier: NCT01434914
Recruitment Status : Terminated (early termination due to poor recruitment)
First Posted : September 15, 2011
Last Update Posted : May 13, 2014
Sponsor:
Information provided by (Responsible Party):
Schülke & Mayr GmbH

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

Condition or disease Intervention/treatment Phase
Ulcus Cruris Drug: octenisept® Drug: Placebo Phase 4

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 9 participants
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
Study Start Date : October 2011
Primary Completion Date : July 2013
Study Completion Date : July 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: verum Drug: octenisept®
Cutaneous solution
Placebo Comparator: Placebo Drug: Placebo
Cutaneous use



Primary Outcome Measures :
  1. 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 :
  1. Subjective tolerance of octenisept® [ Time Frame: 2 weeks after baseline ]
    Clinical signs of tolerance of octenisept®

  2. Evaluation of wound parameters [ Time Frame: 2 weeks after baseline ]
    Evaluation of wound healing time and wound size (Planimetry)



Information from the National Library of Medicine

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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

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

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 Posted: September 15, 2011    Key Record Dates
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