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

Diabetic 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 with a new product, in which a regenerating agent, made of sugar, reactivates at very low doses our natural regeneration potential. In total, 100 patients with ulcers (>4 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.