Chronic leg ulcers MedDRA version: 14.1 Level: LLT Classification code 10068310 Term: Leg ulcer System Organ Class: 100000004858
Conditions
Interventions
Trade Name: octenisept®
Pharmaceutical Form: Cutaneous solution
INN or Proposed INN: OCTENIDINE DIHYDROCHLORIDE
CAS Number: 70775-75-6
Concentration unit: mg/ml milligram(s)/millilitre
Concentration t
Sponsors
Schülke & Mayr GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 - To evaluate the wound healing time and wound size - 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 - Staphylococcus aureus - Streptococcus pyogenes - Enterococcus spp. - Pseudomonas aeruginosa - Escherichia coli - Proteus mirabilis ;Timepoint(s) of evaluation of this end point: After 1 and 2 weeks in comparison to baseline ( determined directly before start of treatment) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Wound size after 2 weeks of treatment - Patient benefit determined with the PBI and FLQA question-naire after 2 weeks of treatment - Descriptive analysis: occurrence of multi-resistant strains - Safety: IMP related Adverse Events ;Timepoint(s) of evaluation of this end point: see above | — |
Countries
Germany
Contacts
Public ContactClinical Trial Informations
Clinical Trial Center North, MediGate GmbH
Outcome results
None listed