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

Study Overview
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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.

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.

Official Title
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Randomized, Double-blind, Single-center, Placebo-controlled Study to Evaluate the Efficacy of Octenisept® in Patients With Chronic Wounds

Conditions
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Ulcus Cruris

Intervention / Treatment
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* Drug: octenisept®
* Drug: Placebo


Participation Criteria
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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 Non-fulfilment of the inclusion criteria

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: verum<br> | Drug: octenisept®<br>* Cutaneous solution<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Cutaneous use<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 Outcome Measures

| Outcome Measure | 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) | 2 weeks after baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ulcus cruris, chronic wounds, octenisept®