Chronic venous leg ulcers In Germany, approximately three million people suffer from chronic leg ulcers of various origins. These ulcers are often very painful and extremely cost-intensive diseases associated with severe reductions of the patients’ quality of life. Vascular ulcers represent 75% of all chronic ulcers in general and are divided into venous (65%) - which is the study indication - and arterial and mixed arterial-venous ulcers (10%). MedDRA version: 9.1 Level: LLT Classification
Conditions
Interventions
Trade Name: Octenisept Wunddesinfektion
Product Name: not applicable
Product Code: not applicable
Pharmaceutical Form: Cutaneous solution
INN or Proposed INN: OCTENIDINE DIHYDROCHLORIDE
CAS Number: 70
Sponsors
Schülke & Mayr GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients who have given their signed declaration of consent and data protection declaration 2. Males and females aged at least 18 years 3. Patients with a locally infected chronic venous leg ulcer (target ulcer) at any location below the knee joint (CVI grade C6 according to CEAP classification= trophic lesions and open ulcer) meeting all of the following criteria: a) confirmed diagnosis of chronic venous insufficiency (CVI) b) presence of at least 2 of the following 9 infection criteria (according to Cutting and White 2005): · abscess · cellulites · discharge: (increased) serous exudate with inflammation, seropurulent, haemopurulent, pus · discoloration: dull brick red (beta-haemolytic streptococci), blue/green (Pseudomonas aeruginosa) · friable granulation tissue which bleeds easily · unexpected pain/tenderness or change in the nature of pain · pocketing at the base of the wound · bridging of the epithelium or soft tissue · abnormal smell c) duration of the target venous ulcer at least 4 weeks and max. 1 year d) surface area of the target venous ulcer (after debridement) min. 2 cm2 and max. 20 cm2 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Duration of target ulcer 1 year 2. Contraindication regarding local wound therapy with local antimicrobial agents(e.g. inflammation requiring systemic antibiotic therapy, malignant ulcer) 3. Contraindications regarding compression therapy with bandages (e.g. progressed peripheral arterial occlusive disease, ABI 1.3) 4. Known hypersensitivity to one or more of the active and/or inactive ingredients of the investigational medicinal product 5. 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 keratinocytes, bioengineered tissue, biophysical modalities 6. Previous or concomitant therapy with non-permitted local or systemic drug therapy (see list below) 7. Indication for non-permitted wound dressings (see below) 8. General exclusion criteria like severe somatopathic, neurological and/or psychiatric disease parallel participation in another study, participation in a study within less than 6 weeks prior to study entry, or previous participation in this same study, known to be, or suspected of being unable to comply with the study protocol (e.g. no permanent address, history of or (and) known drug abuse, known to be non-compliant or presenting an unstable psychiatric history) legal incapacity and/or other circumstances rendering the patient unable to understand the nature, scope and possible impact of the study, patients in custody by juridical or official order, evidence of an uncooperative attitude (non-compliance), patients who have difficulties in understanding the language in which the patient information is given.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: · To investigate the efficacy of topical antimicrobial agent treatment with Octenisept for 12 weeks (maximum duration) in accelerating closure of chronic wounds as compared to standard wound cleansing (Ringer solution) in patients with chronic venous leg ulcers due to chronic venous insufficiency (CVI). Both treatment groups will be prescribed standard treatment for CVI: short-elastic bandages for adequate compression therapy and non-adhesive foams as dressing.;Secondary Objective: · To assess the local tolerance of Octenisept in comparison to Ringer solution applied to chronic venous leg ulcers. · To conduct a prospective controlled clinical study with Octenisept according to current scientific standards that meets the requirements of ICH-GCP. ;Primary end point(s): Time to complete wound closure of the target ulcer (100 % epithelisation) within 12 weeks with Octenisept plus compression therapy versus Ringer solution plus compression therapy in the intention-to-treat (ITT) population [days]. The analysis of the primary endpoint will be based on the date of complete wound closure of the target ulcer recorded by the investigator in the CRF. | — |
Countries
France, Germany, Hungary, United Kingdom
Outcome results
None listed