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

Phase 4

Terminated

• Conditions: Ulcus Cruris
• Interventions: Drug: Placebo; Drug: octenisept®

• Registration Number: NCT01434914
• Lead Sponsor: Schülke & Mayr GmbH

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.

Study Timeline

• Study First Submitted: 2011-09-13
• Study First Submitted QC: 2011-09-14
• Study First Posted: 2011-09-15
• Study Start: 2011-10
• Primary Completion: 2013-07
• Study Completion: 2013-07
• Status Verified: 2014-05
• Last Update Submitted: 2014-05-12
• Last Update Posted: 2014-05-13

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 9

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
verum	octenisept®	-

Primary Outcome Measures

Name	Time	Method
Antimicrobial efficacy of octenisept® compared to placebo	2 weeks after baseline	Decrease of bacterial load after 2 weeks of treatment

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University Medical Center Hamburg-Eppendorf; 🇩🇪 Hamburg, Germany