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: May 12, 2014
Last verified: May 2014
  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
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, see Learn About Clinical Studies.

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: May 12, 2014
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
Leg Ulcer
Skin Diseases
Skin Ulcer
Octenidine
Anti-Infective Agents
Anti-Infective Agents, Local
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014