A new compression system for treatment of venous leg ulcers: a prospective, single-arm, clinical trial (FREEDOM).

To evaluate the efficacy, tolerability and acceptability of a new multicomponent compression system in one bandage for the local treatment of patients with venous leg ulcers (VLUs). This was an international, prospective, non-comparative, clinical trial, conducted in France and Germany. Eligible participants had a VLU with a wound area of 2-20cm A cohort of 52 patients (52% female, mean age 75.4±13.0 years) with VLUs, including oedema in 58% of cases, were recruited from 22 centres. At baseline, 42 patients had already been treated with a different compression system. VLUs had been present for 5.6±4.9 months and had a mean area of 5.7±4.3cm The new multicomponent compression system in one bandage has been shown to promote rapid healing of VLUs, reduce oedema, improve HRQoL and to be well tolerated and accepted. It appears to be a viable alternative to existing compression systems.