Recently, a Phase III clinical trial of hepatocyte growth factor gene therapy in peripheral artery disease (PAD) showed improvement of ischemic ulcers, but it could not salvage limbs from amputation.
Complete ulcer healing at 12 months occurred in 31% of the HGF group and 0% of the placebo (P = .28) There was no difference in major amputation of the treated limb (HGF 29% vs placebo 33%) or mortality at 12 months (HGF 19% vs placebo 17%) between groups.