Ulcus CrurisPhase 4NCT01434914
Study to Evaluate the Efficacy of Octenisept® in Patients With Chronic Wounds
A Phase 4 study testing octenisept® in people with Ulcus Cruris, run by Schülke & Mayr GmbH at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ulcus Cruris
- What is being tested?
- octenisept®
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 9 participants
- Where
- 1 siteGermany
- Study dates
- Oct 2011to Jul 2013
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- Ability to provide written informed consent
- Signed declaration of consent
- Willingness to co-operate
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized, Double-blind, Single-center, Placebo-controlled Study to Evaluate the Efficacy of Octenisept® in Patients With Chronic Wounds
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
- Ulcus Cruris
- Being tested
- octenisept®, Placebo
- Keywords
- Ulcus cruris, chronic wounds, octenisept®
- Medical subject headings
- Foot Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
octenisept®Drug
Cutaneous solution
PlaceboDrug
Cutaneous use
| Study group | Role | What they receive |
|---|---|---|
| verum | Active comparator | Not described Receives: Drug: octenisept® |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Antimicrobial efficacy of octenisept® compared to placebo
Decrease of bacterial load after 2 weeks of treatment
Measured: 2 weeks after baseline
Secondary outcomes (2)
Subjective tolerance of octenisept®
Clinical signs of tolerance of octenisept®
Measured: 2 weeks after baseline
Evaluation of wound parameters
Evaluation of wound healing time and wound size (Planimetry)
Measured: 2 weeks after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2011 (estimated)
- Study startOct 2011
- Primary completionJul 2013
- Study completionJul 2013
Why it stopped: early termination due to poor recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Ulcus CrurisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Schülke & Mayr GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Matthias Augustin, MD, Principal investigator, Universitätsklinikum Hamburg-Eppendorf
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01434914
- Sponsor's protocol ID
- OCT-UKE-2011
- Status last verified
- May 2014
- First submitted
- 13 Sep 2011
- Last updated
- 13 May 2014
- Results posted
- No
- Data monitoring committee
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-blind, Single-center, Placebo-controlled Study to Evaluate the Efficacy of Octenisept® in Patients With Chronic Wounds
- ClinicalTrials.gov ID
- NCT01434914
- Acronym / sponsor ID
- OCT-UKE-2011
- Conditions
- Ulcus Cruris
- Keywords
- Ulcus cruris, chronic wounds, octenisept®
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: early termination due to poor recruitment
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Schülke & Mayr GmbHIndustry (pharma, biotech, devices)
- Study start
- Oct 2011
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 15 Sep 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| verum | Active comparator | Drug: octenisept® |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| octenisept®Cutaneous solution | Drug | verum |
| PlaceboCutaneous use | Drug | Placebo |
Primary outcome
Antimicrobial efficacy of octenisept® compared to placebo
Time frame: 2 weeks after baseline
Decrease of bacterial load after 2 weeks of treatment
2 secondary outcomes
Subjective tolerance of octenisept®
Time frame: 2 weeks after baseline
Evaluation of wound parameters
Time frame: 2 weeks after baseline
Results and safety
The study was stopped early (reason given: early termination due to poor recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2014.
- BackgroundVanscheidt 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: PubMed 20484966Hubner 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.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matthias Augustin, MD principal investigator
Universitätsklinikum Hamburg-Eppendorf
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing octenisept® in people with Ulcus Cruris, run by Schülke & Mayr GmbH at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 13 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: early termination due to poor recruitment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Antimicrobial efficacy of octenisept® compared to placebo (time frame: 2 weeks after baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01434914, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2014.