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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01434914
• Other study ID #: OCT-UKE-2011
• Status: Terminated
• Phase: Phase 4
• First received: September 13, 2011
• Last updated: May 12, 2014
• Start date: October 2011
• Est. completion date: July 2013

Study information

• Verified date: May 2014
• Source: Schülke & Mayr GmbH
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 9
• Est. completion date: July 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

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

Intervention

Drug:
• octenisept®
Cutaneous solution
• Placebo
Cutaneous use

Locations

Country	Name	City	State
Germany	University Medical Center Hamburg-Eppendorf	Hamburg

Sponsors (1)

Lead Sponsor	Collaborator
Schülke & Mayr GmbH

Country where clinical trial is conducted

Germany, 

References & Publications (2)

Hübner NO, Siebert J, Kramer A. Octenidine dihydrochloride, a modern antiseptic for skin, mucous membranes and wounds. Skin Pharmacol Physiol. 2010;23(5):244-58. doi: 10.1159/000314699. Epub 2010 May 18. Review. — View Citation

Vanscheidt W, Baer M, May TW, Siebert J.: Affecting the wound healing process of chronic ulcera by an octenidine based wound antiseptic. Hyg Med (2005) 30 (5): 153-8

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Antimicrobial efficacy of octenisept® compared to placebo	Decrease of bacterial load after 2 weeks of treatment	2 weeks after baseline	No
Secondary	Subjective tolerance of octenisept®	Clinical signs of tolerance of octenisept®	2 weeks after baseline	No
Secondary	Evaluation of wound parameters	Evaluation of wound healing time and wound size (Planimetry)	2 weeks after baseline	No

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