search
Back to results

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

Primary Purpose

Ulcus Cruris

Status
Terminated
Phase
Phase 4
Locations
Germany
Study Type
Interventional
Intervention
octenisept®
Placebo
Sponsored by
Schülke & Mayr GmbH
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ulcus Cruris focused on measuring Ulcus cruris, chronic wounds, octenisept®

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Medical Center Hamburg-Eppendorf

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

verum

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Antimicrobial efficacy of octenisept® compared to placebo
Decrease of bacterial load after 2 weeks of treatment

Secondary Outcome Measures

Subjective tolerance of octenisept®
Clinical signs of tolerance of octenisept®
Evaluation of wound parameters
Evaluation of wound healing time and wound size (Planimetry)

Full Information

First Posted
September 13, 2011
Last Updated
May 12, 2014
Sponsor
Schülke & Mayr GmbH
search

1. Study Identification

Unique Protocol Identification Number
NCT01434914
Brief Title
Study to Evaluate the Efficacy of Octenisept® in Patients With Chronic Wounds
Official Title
Randomized, Double-blind, Single-center, Placebo-controlled Study to Evaluate the Efficacy of Octenisept® in Patients With Chronic Wounds
Study Type
Interventional

2. Study Status

Record Verification Date
May 2014
Overall Recruitment Status
Terminated
Why Stopped
early termination due to poor recruitment
Study Start Date
October 2011 (undefined)
Primary Completion Date
July 2013 (Actual)
Study Completion Date
July 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Schülke & Mayr GmbH

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ulcus Cruris
Keywords
Ulcus cruris, chronic wounds, octenisept®

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
9 (Actual)

8. Arms, Groups, and Interventions

Arm Title
verum
Arm Type
Active Comparator
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
octenisept®
Intervention Description
Cutaneous solution
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Cutaneous use
Primary Outcome Measure Information:
Title
Antimicrobial efficacy of octenisept® compared to placebo
Description
Decrease of bacterial load after 2 weeks of treatment
Time Frame
2 weeks after baseline
Secondary Outcome Measure Information:
Title
Subjective tolerance of octenisept®
Description
Clinical signs of tolerance of octenisept®
Time Frame
2 weeks after baseline
Title
Evaluation of wound parameters
Description
Evaluation of wound healing time and wound size (Planimetry)
Time Frame
2 weeks after baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Matthias Augustin, MD
Organizational Affiliation
Universitätsklinikum Hamburg-Eppendorf
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Medical Center Hamburg-Eppendorf
City
Hamburg
Country
Germany

12. IPD Sharing Statement

Citations:
Citation
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
Results Reference
background
PubMed Identifier
20484966
Citation
Hubner NO, Siebert J, Kramer A. Octenidine dihydrochloride, a modern antiseptic for skin, mucous membranes and wounds. Skin Pharmacol Physiol. 2010;23(5):244-58. doi: 10.1159/000314699. Epub 2010 May 18.
Results Reference
background
Links:
URL
http://www.schuelke.com
Description
Related Info

Learn more about this trial

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

We'll reach out to this number within 24 hrs