This study was carried out to assess the efficacy and tolerability of the topical application of an aqueous extract of Triticum vulgare (TV) in different vehicles (cream, impregnated gauzes, foam, hydrogel, and dressing gel) for the treatment of venous lower leg ulcers. Fifty patients were randomized to receive one of the five investigational vehicles. Treatment was performed up to complete healing or to a maximum of 29 days. The wound size reduction from baseline was the primary efficacy variable, which was measured by means of a noninvasive laser scanner instrument for wound assessment. In all groups, apart from the foam group, a similar trend toward the reduction of the surface area was observed. The cream showed the greatest effect on the mean reduction of the lesion size. At last visit, six ulcers were healed: two in the cream group, three in the gauze group, and one in the dressing gel group. In the patients treated with the cream, the gauzes, the hydrogel, and the dressing gel, the reduction of lesion size was 40%–50%; the reduction was smaller in the foam group. No impact in terms of age on the healing process was found. The Total Symptoms Score decreased in all groups during the study; a greater efficacy in terms of signs/symptoms was observed in the patients treated with the gauzes. In the dressing gel group, one patient had an infection of the wound after 3 weeks of treatment and 2 of colonization, leading to a systemic antibiotic treatment. The events were judged as nonrelated to the device used. On the basis of the results, it could be argued that the medical device may be useful in the treatment of chronic venous ulcers.

The results of this study showed the effectiveness and safety of a collagen dressing in hard-to-heal vlUs as an adjunctive therapy with compression bandaging. These encouraging results may positively affect the quality of life of patients with chronic wounds.

The EU FP7 SWAN-iCare project aims at developing an integrated autonomous device for the monitoring and the personalized management of chronic wounds, mainly diabetic foot ulcers and venous leg ulcers. Most foot and leg ulcers are caused by diabetes and vascular problems respectively but a remarkable number of them are also due to the co-morbidity influence of many other diseases (e.g. kidney disease, congestive heart failure, high blood pressure, inflammatory bowel disease). More than 10 million people in Europe suffer from chronic wounds, a number which is expected to grow due to the aging of the population. The core of the project is the fabrication of a conceptually new wearable negative pressure device equipped with Information and Communication Technologies. Such device will allow users to: (a) accurately monitor many wound parameters via non-invasive integrated micro-sensors, (b) early identify infections and (c) remotely provide an innovative personalized two-line therapy via non-invasive micro-actuators to supplement the negative pressure wound therapy. This paper describes the main components of the SWAN-iCare system and its potential impact in the area of wound management

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