Effect of Prontosan Wound Irrigation Solution on Venous Ulcers

Investigational product, dose and administration:

Prontosan® Wound Irrigation Solution (experimental group) and saline solution (control group)
will be applied at inclusion and reapplied after dressing changes.

The treatment scheme is as follows:

1. Prontosan® Wound Irrigation Solution (experimental group):

- cleansing the wound bed at dressing change with Prontosan® Wound Irrigation
Solution; a sterile gauze dressing impregnated with the Prontosan® solution will be
placed on the immediate wound in the form of a moist compress and removed after
approximately 15 minutes;

- placing the primary dressing (Profore® WCL): the dressing will be impregnated with
Prontosan® Wound Irrigation Solution;

- fixing the dressing to the wound using multilayered elastic compression bandaging
(Profore® bandaging system).

2. Saline (control group):

- cleansing the wound bed at dressing change with saline; a sterile gauze dressing
impregnated with the saline will be placed on the wound in the form of a moist
compress and removed after approx.15 minutes;

- placing the primary dressing (Profore® WCL): the dressing will be impregnated with
saline;

- fixing the dressing to the wound using multilayered elastic compression bandaging
(Profore® bandaging system).

Dressings will be changed and the treatment procedure will be repeated in the clinic
2x/weekly or more. The efficacy of the treatment procedure will be evaluated on the basis of
a 2 week observation period.

Treatment efficacy assessment:

- Assessment of clinical signs and symptoms at entry to the study and after one and two
weeks.

- Quantitative and qualitative microbiological analysis at entry to the study and after
two weeks.

- Wound planimetry using PictZar® CDM at entry to the study and after two weeks.

Primary aim:

- clinical signs assessed by:

1. reduction of slough and necrotic tissue

2. control of exudate

3. presence of granulation tissue

- reduction of inflammatory signs (surrounding skin)

- reduction in wound size (assessed by wound planimetry)

- reduction of bacterial load (quantitative and qualitative microbiological

Secondary aim:

- tolerance and safety assessment:

1. adverse drug reaction

2. adverse events

3. early withdrawal from the study

Inclusion Criteria:

- males and females aged at least 18 with wounds of venous aetiology (documented by
targeted exams) located in the lower limbs

- Ankle Brachial Index (ABI) ≥ 0.7

- patients who have not had an antimicrobial (systemic antibiotic or topical antiseptic)
over the 30 days before joining the study

Exclusion Criteria:

Exclusion criteria

- age below 18 years

- presence of clinical infection, or current use of antiseptics or antibiotics

- chronic wounds of long duration (>30cm2 and >1 year duration)

- involvement in other wound related trials within the past 30 days

- sensitivity to any of the components of Prontosan® or dressing material

- intolerance to compression therapy

- active osteomyelitis in the ulceration area

- active rheumatoid arthritis (RA) requiring any immunosuppressive therapy

- collagen vascular disease active treated with steroids

- chronic diseases that could impact the course of the study (malicious cancer, TB,
AIDS, mental illnesses)

- plasma protein below 4 g/dl

- anaemia: haemoglobin below 10 g/dl

- both, controlled and uncontrolled diabetics (type 1 or 2)

- patients on any rheological agents (not including aspirin)