OTR4120: topical application at venous ulcers. A clinical evaluation of cicatrisation.

Venous ulcers are, in aging Western societies, an increasing problem and
display a significant impact on the quality of life of patients and on
health economics.



This study aims to investigate, in a double blinded, randomized
controlled trial, the effectiveness of treatment of chronic wounds
(venous ulcers) with a new product, in which a regenerating agent, made
of sugar, reactivates at very low doses our natural regeneration
potential. In total, 70 patients with venous ulcers (>6 months open with
no or insufficient signs of healing) will be included. The ulcer(s) will
be cleaned and the product will be applied for only 5 minutes and
removed. This is enough to this sugar to stabilize the wound and to
allow the tissue to repair. This treatment will be followed by standard
care. The study is for a duration of 16 weeks for each patient. From
preliminary studies a dramatic reduction of ulcer size, time to complete
healing and pain are expected without any side effect.

OTR4120 will improve healing of chronic ulcers.

week: 0,5; 1; 1.5; 2; 2.5; 3; 3.5; 4; 6; 8; 10; 12; 14; 16.

For the OTR4120-group, the medical device Cacipliq20
consists of a sterile solution of OTR4120 (100microgram/ml) in
physiological salt.




For the placebo group the medical device Cacipliq20 consists of a
sterile solution of physiological salt.