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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

9 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-10-31

Study Completion Date

2013-07-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Ulcus Cruris

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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verum

Group Type ACTIVE_COMPARATOR

octenisept®

Intervention Type DRUG

Cutaneous solution

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Cutaneous use

Interventions

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octenisept®

Cutaneous solution

Intervention Type DRUG

Placebo

Cutaneous use

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No