Vivostat A/S (Vivostat ), a developer of wound care market, is planning to complete the clinical trial entitled “A Cohort Study to Evaluate the Effect of Vivostat Platelet Rich Fibrin on Diabetic Foot Ulcers” for the product Vivostat Platelet Rich Fibrin by October 2010. The trial will evaluate the healing effect of Vivostat PRF treatment of non-eschemic foot ulcers to identify responders and to enable sample size calculation for a subsequent pivotal trial. This multi-centre study is being conducted in Denmark, Germany, Sweden.
The phase IV open label, uncontrolled, single group assignment, efficacy study currently recruiting participants with an estimated enrollment of 60. The study director is Anne Kvistgaard, MSc from Vivostat.
Vivostat Platelet Rich Fibrin (PRF) is second generation Vivostat product designed for the preparation and application of autologous fibrin sealant. By combining a fibrin sealant solution with a platelet concentrate, it is possible to have a carrier, a controlled release and a medium for vascular ingrowth. Vivostat PRF contains a variety of potent growth factors that stimulate fibroblast proliferation and tissue synthesis.