Study to Evaluate the Efficacy of Octenisept® in Patients With Chronic Wounds
This study is currently recruiting participants.
Verified June 2012 by Schülke & Mayr GmbH
Sponsor:
Schülke & Mayr GmbH
Information provided by (Responsible Party):
Schülke & Mayr GmbH
ClinicalTrials.gov Identifier:
NCT01434914
First received: September 13, 2011
Last updated: June 26, 2012
Last verified: June 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Ulcus Cruris |
Drug: octenisept® Drug: Placebo |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | Randomized, Double-blind, Single-center, Placebo-controlled Study to Evaluate the Efficacy of Octenisept® in Patients With Chronic Wounds |
Further study details as provided by Schülke & Mayr GmbH:
Primary Outcome Measures:
- Antimicrobial efficacy of octenisept® compared to placebo [ Time Frame: 2 weeks after baseline ] [ Designated as safety issue: No ]Decrease of bacterial load after 2 weeks of treatment
Secondary Outcome Measures:
- Subjective tolerance of octenisept® [ Time Frame: 2 weeks after baseline ] [ Designated as safety issue: No ]Clinical signs of tolerance of octenisept®
- Evaluation of wound parameters [ Time Frame: 2 weeks after baseline ] [ Designated as safety issue: No ]Evaluation of wound healing time and wound size (Planimetry)
| Estimated Enrollment: | 70 |
| Study Start Date: | October 2011 |
| Estimated Study Completion Date: | December 2012 |
| Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: verum |
Drug: octenisept®
Cutaneous solution
|
| Placebo Comparator: Placebo |
Drug: Placebo
Cutaneous use
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01434914
Contacts
| Contact: Jörg Siebert, PhD | +49 40 52100 ext 534 | joerg.siebert@schuelke.com |
| Contact: Nicole Steinhorst, MD | +49 40 52100 ext 173 | nicole.steinhorst@schuelke.com |
Locations
| Germany | |
| University Medical Center Hamburg-Eppendorf | Recruiting |
| Hamburg, Germany | |
| Contact: Matthias Augustin, MD +49 40 7410 ext 55428 m.augustin@uke.de | |
| Principal Investigator: Matthias Augustin, MD | |
Sponsors and Collaborators
Schülke & Mayr GmbH
Investigators
| Principal Investigator: | Matthias Augustin, MD | Universitätsklinikum Hamburg-Eppendorf |
More Information
Additional Information:
Publications:
| Responsible Party: | Schülke & Mayr GmbH |
| ClinicalTrials.gov Identifier: | NCT01434914 History of Changes |
| Other Study ID Numbers: | OCT-UKE-2011 |
| Study First Received: | September 13, 2011 |
| Last Updated: | June 26, 2012 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Keywords provided by Schülke & Mayr GmbH:
|
Ulcus cruris chronic wounds octenisept® |
Additional relevant MeSH terms:
|
Foot Ulcer Foot Diseases Skin Diseases Leg Ulcer Skin Ulcer |
Octenidine Anti-Infective Agents, Local Anti-Infective Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 22, 2013