In the VITRO-CARD-1001 study in a population of patients with previous unsuccessful treatment of their wounds and with a median wound duration of 10 months at baseline, a clinically meaningful overall complete healing rate of 30.2% was achieved in the Full Analysis Set (FAS) and a healing rate of 35.6% in the Completer Analysis Set (CAS) by the end of the 12-week treatment period.
A clinically meaningful median percentage wound area reduction of 61.9% between baseline and final assessment was achieved in the FAS and a median of 70.8% in the CAS. At end of study, 31/53 patients (58.5%) had achieved partial healing by at least 50%, 22/53 patients (41.5%) had achieved partial healing by at least 75% and 16/53 patients (30.2%) had complete healing (i.e. 100% epithelialisation).
In the VITRO-CARD-1001 study, in addition to the achievement of clinically meaningful healing and wound area reduction, patients also achieved substantial pain reduction.
Ulcer pain is a common feature of VLUs. A study by Phillips et al. in 1994 found that 65% of patients with VLUs complained of severe pain . In addition, a study by Antignani et al. found that 68% of patients stated that their ulcer created a negative emotional and psychological impact including feelings of fear, social isolation, anger, depression, anxiety, and negative self-image.
In the VITROCARD- 1001 study there were 28/53 patients (52.8%) who reported pain at their initial assessment. Of these 20/28 (71.4%) reported no pain at their last assessment (12 weeks, healing or withdrawal, whichever came first). Moreover, 27 of these 28 patients (96.4%) had meaningful pain reduction (i.e. at least 33% reduction in pain) and 22/28 patients (78.6%) had reduction to no pain during the study.
Phillips, T. et al. Study of the impact of leg ulcers on quality of life: financial, social, and psychologic implications. Journal of the American Academy of Dermatology. 1994.
Antignani PL. Classification of chronic venous insufficiency: a review. Angiology. 2001.