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

Randomized, Double-blind, Single-center, Placebo-controlled Study to Evaluate the Efficacy of Octenisept® in Patients With Chronic Wounds

Status

Terminated

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01434914

Enrollment

Registered

2011-09-15

Start date

2011-10-31

Completion date

2013-07-31

Last updated

2014-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ulcus Cruris

Keywords

Ulcus cruris, chronic wounds, octenisept®

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.

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.

Interventions

DRUGoctenisept®

Cutaneous solution

DRUGPlacebo

Cutaneous use

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

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

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026