Ongoing Clinical Studies

Current Feasibility Clinical Studies on PRP and PRFM:

Three double-arm, randomized clinical trials of 200 patients, total (100 in each arm).

Diabetic Foot Ulcers

This study will assess the efficacy of the CASCADE® Autologous Platelet System and compare its performance with the usual and customary practice (UCP) for the treatment of chronic diabetic foot ulcers (DFUs). This is a prospective, randomized, controlled, multi-center study for subjects undergoing DFU treatment. Subjects will be randomly assigned (1:1) to two groups: a test group being treated with the CASCADE® Autologous Platelet System’s protocols and a control group (being treated via UCPs).

Venous Leg Ulcers

This study will assess the efficacy of the CASCADE® Autologous Platelet System and compare its performance with the usual and customary practice (UCP) for the treatment of chronic non-healing venous leg ulcers (VLUs). This is a prospective, randomized, controlled, multi-center study for subjects undergoing VLU treatment. Subjects will be randomly assigned (1:1) to two groups: a test group being treated with the CASCADE® Autologous Platelet System’s protocols and a control group (being treated via UCPs).

Pressure Ulcers

This study will assess the efficacy of the CASCADE® Autologous Platelet System and compare its performance with the usual and customary practice (UCP) for the treatment of chronic nonhealing pressure ulcers (PrUs). This is a prospective, randomized, controlled, multi-center study for subjects undergoing PrU treatment. Subjects will be randomly assigned (1:1) to two groups: a test group being treated with the CASCADE® Autologous Platelet System’s protocols and a control group (being treated via UCPs).