TerminatedNCT01434914Updated May 13, 2014

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

A Phase 4 interventional study of octenisept® and Placebo in Ulcus Cruris, sponsored by Schülke & Mayr GmbH. Terminated at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-05-13.

Sponsored by Schülke & Mayr GmbH · Phase 4, Interventional, and Treatment

Why this study was terminated

early termination due to poor recruitment

Phase: Phase 4
Study type: Interventional
Enrollment: 9
Allocation: Randomized
Ages: 18 Years and older
Sex: All

Study 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.

Read the 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.

Conditions studied

Ulcus Cruris

Browse trials for

Foot Ulcer 691

Keywords

Ulcus cruris
chronic wounds
octenisept®

In context

Foot Ulcer

691 studies on the registry are indexed under Foot Ulcer; 96 are open to participants now.

This study's enrollment of 9 is below the median of 60 across 562 interventional studies indexed under Foot Ulcer.

Browse Foot Ulcer studies →

Lead sponsor

Schülke & Mayr GmbH is the lead sponsor of 4 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

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

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

Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Double (Participant, Investigator)
Enrollment: 9 participants (actual)

Study arms

Active comparator
verum
Drug: octenisept®
Placebo comparator
Placebo
Drug: Placebo

Interventions

Drugoctenisept®
Cutaneous solution
DrugPlacebo
Cutaneous use

What researchers measure

Primary outcomes

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

Secondary outcomes

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

Study locations

1 site

University Medical Center Hamburg-Eppendorf
Hamburg, Germany

References and documents

Publications

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
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. PubMed 20484966 ↗

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on May 13, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01434914
Lead sponsor: Schülke & Mayr GmbH
Responsible party: Sponsor
First posted: Sep 15, 2011
Start date: Oct 2011
Primary completion: Jul 2013
Completion: Jul 2013
Last update: May 13, 2014

Study contacts

Matthias Augustin, MD

principal investigator · Universitätsklinikum Hamburg-Eppendorf

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in May 2014. You cannot join it, but the record below documents what was studied.

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