This study was one of the few studies to objectively show a positive effect of VLNT in a prospective clinical multicenter setting. It was also the first-ever randomized prospective clinical study showing a quantitatively positive effect of a medical therapy on the edema of lymphedema although failing to show differences between groups in primary outcome measures.
During 24 months' of follow-up, the results indicate that Lymfactin® is well tolerated. The most promising findings were a 46% reduction in excess arm volume and a nonsignificant volume increase after garment removal at 12 months, suggesting that there is potential for the reduction of lymphedema.
Due to the nature of the study, there are no set formal statistical hypotheses for the efficacy endpoints, but suitable inferential statistics can be used when feasible.Present accrual and target accrual: A total of 40 patients are planned to be included in the clinical study. By the end of June 2019, 15 patients have been enrolled.Contact: Outi Lahdenperä, MDCMOHerantis Pharma PlcE-mail: outi.lahdenpera@herantis.com Tel: +358 40 511 3194