Study to Evaluate the Efficacy of Octenisept® in Patients... | NCT01434914

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

NCT01434914

Sponsor

Schülke & Mayr GmbH

Status

Terminated

Last Update Posted

May 13, 2014Estimated

Enrollment

9Actual

Phase

Phase 4

Conditions

Ulcus Cruris

Interventions

octenisept®
Placebo

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2014

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

early termination due to poor recruitment

Expanded Access Info

Start Date

Oct 2011

Primary Completion Date

Jul 2013Actual

Completion Date

Jul 2013Actual

First Submitted Date

Sep 13, 2011

First Submission Date that Met QC Criteria

Sep 14, 2011

First Posted Date

Sep 15, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 12, 2014

Last Update Posted Date

May 13, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

9Actual

Label	Type	Description	Intervention Names
verum	Active Comparator		Drug: octenisept®
Placebo	Placebo Comparator		Drug: Placebo

Name	Type	Description	Arm Group Labels	Other Names
octenisept®	Drug	Cutaneous solution	verum
Placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Antimicrobial efficacy of octenisept® compared to placebo	Decrease of bacterial load after 2 weeks of treatment	2 weeks after baseline

Secondary Outcomes

Measure	Description	Time Frame
Subjective tolerance of octenisept®	Clinical signs of tolerance of octenisept®	2 weeks after baseline
Evaluation of wound parameters	Evaluation of wound healing time and wound size (Planimetry)

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Matthias Augustin, MD	Universitätsklinikum Hamburg-Eppendorf	Principal Investigator

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
	Background	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
20484966	Background	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.

ID	Term
D005534	Foot Diseases
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases
D007871	Leg Ulcer