Randomized, Double-blind, Single-center, Placebo-controlled Study to evaluate the Efficacy of octenisept® in Patients with Chronic Wounds.

• Conditions: Chronic leg ulcers; MedDRA version: 14.1Level: LLTClassification code 10068310Term: Leg ulcerSystem Organ Class: 100000004858; Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

• Registration Number: EUCTR2011-003402-25-DE
• Lead Sponsor: Schülke & Mayr GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-08-25
• Last Update Posted: 15 July 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

- Male and female patients of at least 18 years at the time of consent
- Females of non-childbearing potential (postmenopausal = 50 years old and amenorrhea = 12 month after break of exoge-nous hormones or = 50 years old, documented FSH – and LH level equal to the postmenopausal range and amenor-rhea = 12 after break of all exogenous hormones)
- Females of non-childbearing potential due to postoperative bilateral tubal ligation, bilateral salpingectomy, bilateral oo-phorectomile or hysterectomy
- Patients with a venous leg ulcer (Ulcus cruris)
- Patients with a chronic leg ulcer
- Duration of the target venous ulcer = 4 weeks
- Surface area of the target venous ulcer (after debridement) = 1
- Patients with a chronic leg ulcer with bacterial load suspected in at least one of the following bacterial species:
o Staphylococcus aureus
o Streptococcus pyogenes
o Enterococcus spp.
o Escherichia coli
o Proteus mirabilis
o Pseudomonas aeruginosa
- Satisfactory medical assessment with no clinically significant or relevant abnormalities as determined by medical history, physical examination, clinical [vital signs, 12-lead electro-cardiogram (ECG)], and clinical laboratory evaluation (hematology, biochemistry, urinalysis) as assessed by the In-vestigator
- Ability to provide written informed consent
- Signed declaration of consent
- Willingness to cooperate

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 14
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 56

Exclusion Criteria

- Females of childbearing potential
- Known history of alcohol or drug abuse
- Patients with a serious concomitant disease (serious coronary heart disease, serious heart failure (NYHA III or IV), serious nephrotic - or hepatic dysfunction, malign disease, dementia) will be excluded if the investigator decides that study inclusion is not recommended.
- 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
- Contraindication regarding local wound therapy with local antimicrobial agents (e.g. inflamma-tion requiring systemic antibiotic therapy, malignant ulcer)
- Planned ulcer treatment within the treatment period after Visit 1 e.g. surgery on varicose veins (laser coagulation, sclerotherapy, stripping), skin grafting, application of cultured keratino-cytes, bioengineered tissue, biophysical modalities
- Not permitted therapy within the last 7 days prior to the first dose:
• use of any systemic antibiotics
• local antimicrobial agents and topical steroid treatment of the target ulcer (these drugs confound the efficacy of the investigational drug)
- Concomitant treatment with other preparations that interfere with the trial preparation or the disease
- Absence of declaration of consent
- Doubt about willingness to cooperate
- Non-fulfillment of the inclusion criteria
- Staff of the study centre, the investigator him/herself or close relatives of the investigators

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Efficacy of octenisept® compared to NaCl solution and antimicrobial effect in chronic wounds. Decrease of bacterial load after 14 days of treatment will be used as a parameter for efficacy. Bacterial count will be defined with a semi-quantitative bacterial swab.;Secondary Objective: - To assess subjective tolerance of octenisept® using the PBI and FLQA questionnaire<br>- To evaluate the wound healing time and wound size<br>- Development of bacterial load at the follow-up visit ;Primary end point(s): Reduction of the log sum of standardized bacterial densities of 6 bacteria species after 1 and 2 weeks in comparison to baseline determined directly before start of treatment<br>- Staphylococcus aureus <br>- Streptococcus pyogenes <br>- Enterococcus spp.<br>- Pseudomonas aeruginosa<br>- Escherichia coli<br>- Proteus mirabilis<br>;Timepoint(s) of evaluation of this end point: After 1 and 2 weeks in comparison to baseline ( determined directly before start of treatment)

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): - Wound size after 2 weeks of treatment<br>- Patient benefit determined with the PBI and FLQA question-naire after 2 weeks of treatment <br>- Descriptive analysis: occurrence of multi-resistant strains<br>- Safety: IMP related Adverse Events<br>;Timepoint(s) of evaluation of this end point: see above