Effect of an octenidine-based topical antimicrobial agent (Octenisept) on wound healing of chronic venous leg ulcers: a prospective, twelve week comparison versus local treatment with Ringer solution. A randomised, double-blind, controlled, parallel-group, multicentre, multinational Phase IIIb study

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 240

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
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

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.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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