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

This study has been terminated.
(early termination due to poor recruitment)
Sponsor:
Information provided by (Responsible Party):
Schülke & Mayr GmbH
ClinicalTrials.gov Identifier:
NCT01434914
First received: September 13, 2011
Last updated: August 6, 2013
Last verified: August 2013
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

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 ] [ Designated as safety issue: No ]
    Decrease of bacterial load after 2 weeks of treatment


Secondary Outcome Measures:
  • Subjective tolerance of octenisept® [ Time Frame: 2 weeks after baseline ] [ Designated as safety issue: No ]
    Clinical signs of tolerance of octenisept®

  • Evaluation of wound parameters [ Time Frame: 2 weeks after baseline ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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:
Responsible Party: Schülke & Mayr GmbH
ClinicalTrials.gov Identifier: NCT01434914     History of Changes
Other Study ID Numbers: OCT-UKE-2011
Study First Received: September 13, 2011
Last Updated: August 6, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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, Local
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014