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

• Status: Terminated
• Trial end date: 2013-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Schülke & Mayr GmbH
• Treatments: Octenidine

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