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

Ulcus Cruris Clinical Trial

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

Status Terminated

Clinical Trial 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.

Clinical Trial 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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Foot Ulcer
• Ulcus Cruris

• NCT number: NCT01434914
• Study type: Interventional
• Source: Schülke & Mayr GmbH
• Status: Terminated
• Phase: Phase 4
• Start date: October 2011
• Completion date: July 2013