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

Schülke & Mayr

Status and phase: Terminated; Phase 4

Conditions: Ulcus Cruris

Treatments: Drug: octenisept®; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01434914

OCT-UKE-2011

Details and patient eligibility

About

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.

Full 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.

Enrollment: 9 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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9 participants in 2 patient groups, including a placebo group

verum

Active Comparator group

Treatment:

Drug: octenisept®

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo