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

NCT01434914 | Terminated Phase 4

• 1 other identifier: OCT-UKE-2011
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

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.

Conditions

Ulcus Cruris

Keywords

Ulcus cruris; chronic wounds; octenisept®

Outcome Measures

Primary Outcomes (1)

• Antimicrobial efficacy of octenisept® compared to placebo

  Decrease of bacterial load after 2 weeks of treatment

  2 weeks after baseline

Secondary Outcomes (2)

• Subjective tolerance of octenisept®

  2 weeks after baseline

• Evaluation of wound parameters

  2 weeks after baseline

Study Arms (2)

verum

ACTIVE COMPARATOR

Drug: octenisept®

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

octenisept® DRUG

Cutaneous solution

verum

Placebo DRUG

Cutaneous use

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Schülke & Mayr GmbH: lead

Study Sites (1)

University Medical Center Hamburg-Eppendorf

Hamburg, Germany

Location

Related Publications (2)

• 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

  BACKGROUND

• Hubner 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.

  PMID: 20484966 BACKGROUND

Related Links

• Related Info

MeSH Terms

Conditions

Foot Ulcer

Interventions

octenidine and phenoxyethanol drug combination

Condition Hierarchy (Ancestors)

Foot Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Leg Ulcer; Skin Ulcer

Study Officials

• Matthias Augustin, MD

  Universitätsklinikum Hamburg-Eppendorf

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2011
• First Posted: September 15, 2011
• Study Start: October 1, 2011
• Primary Completion: July 1, 2013
• Study Completion: July 1, 2013
• Last Updated: May 13, 2014

Record last verified: 2014-05

Locations

DE (1)