Safety and efficacy of patient specific intramuscular injection of HGF plasmid gene therapy on limb perfusion and wound healing in patients with ischemic lower extremity ulceration: results of the HGF-0205 trial.

Objectives: We have previously reported the results of a dose-finding phase II trial showing that HGF angiogenic gene therapy can increase TcPO2 compared with placebo in patients with critical limb ischemia (CLI). The purpose of this randomized placebo controlled multi-center trial was to further assess the safety and clinical efficacy of a modified HGF gene delivery technique in patients with CLI and no revascularization options.

Methods: Patients with lower extremity ischemic tissue loss (Rutherford 5 and 6) received three sets of eight intramuscular injections every 2 weeks of HGF plasmid under duplex ultrasound guidance.

Cryoplasty for the treatment of femoropopliteal arterial disease: extended follow-up results.

Purpose: To report the findings from a multicenter study of patients treated with cryoplasty who were then followed for an average of > 2 years post-treatment.

Methods: Extended clinical follow-up was obtained for 70 patients (45 men; mean age 70.5 +/- 8.

Cryoplasty for the treatment of femoropopliteal arterial disease: results of a prospective, multicenter registry.

Purpose: Despite suboptimal results, angioplasty of femoropopliteal arterial lesions has been a mainstay of endovascular therapy for many years. The recent introduction of cryoplasty marks a potential advance in the ability to effectively treat peripheral arterial atherosclerotic stenoses. This article presents the results of a prospective, multicenter trial that evaluated the efficacy of cryoplasty for femoropopliteal disease.