E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10066677 |
E.1.2 | Term | Chronic leg ulcer |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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 dressings |
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E.2.2 | Secondary objectives of the trial |
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 meet the requirements of ICH-GCP. |
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E.2.3 | Trial contains a sub-study | Yes |
E.2.3.1 | Full title, date and version of each sub-study and their related objectives |
Sub study on pharmacoeconomic aspects only in Germany |
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E.3 | Principal 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 a least 2 of the following 9 infection criteria (according to Cutting and White 2005) °abscess °cellulitis °discharge: (increased) serous exudate with inflammation, seropurulent, heamopurulent, pus °discoloration: dull brick red (beta-heamolytic Streptoccoci), blue/gree (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 >= 4 weeks and <= 1 year d) surface area of the target venous ulcer (after debridement) >= 2 cm2 <= 20 cm2 |
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E.4 | Principal exclusion criteria |
1. Duration of the target ulcer < 4 weeks and > 1 year 2. Contraindications relating to local wound therapy with local antimicrobial agents (e.g. inflammation requiring systemic antibiotic therapy, malignant ulcer) 3. Contraindications relating to compression therapy with bandages (e.g. progressive peripheral occlusive disease, ABI <0.8 or > 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, bioenginnered tissue, biophysical modalites 6. Previous or concomitant therapy with non-permitted local or systemic drug therapy 7. Indication for non-permitted wound dressings 8. General exclusion criteria such as 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 to the same study-, known to be or suspected of being unable to comply with the protocol (e.g. no permanent address, history of and/or 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 with understanding the language in which the patient information is given. |
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E.5 End points |
E.5.1 | 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. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | Yes |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 6 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 25 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 4 |