This study was an institutional review board-approved, registered, prospective, randomized, comparative clinical trial involving patients with diabetic foot ulcers (DFUs).
In this study, the patients with non-infected ulcers of greater than four weeks duration were evaluated during a two week run-in period. If a wound area reduced by 20% or more at the end of the run-in period, the subject was excluded.
Those patients whose wounds did not exhibit rapid closure under conservative care totaled 40 in number, and were included in the study and randomized to receive either weekly or biweekly application of EpiFix.
In addition, all weekly and biweekly application study subjects received a non-adherent, moist dressing with compressive wrapping, and all wounds were off loaded. The primary study outcome was mean time to healing.
In the 12 week study period, 37 out of 40 patients, or 92.5%, of the DFUs healed completely. Of these 37 patients, the mean time to complete healing was 2.4 weeks for those patients receiving weekly applications and 4.1 weeks for those receiving biweekly applications.
These findings show that wounds treated with weekly applications heal more rapidly, and that even the wounds treated with biweekly applications had rapid healing rates.
