Insights on the Role of Diabetes and Geographic Variation in Patients with Criticial Limb Ischaemia

摘要: Abstract Background Patients with critical limb ischaemia (CLI) unsuitable for revascularisation have a high rate of amputation and mortality (30% 25% at 1 year, respectively). Localised gene therapy using plasmid DNA encoding acidic fibroblast growth factor (NV1FGF, riferminogene pecaplasmid) has showed an increased amputation-free survival in phase II trial. This article provides the rationale, design baseline characteristics CLI patients enrolled pivotal III trial (EFC6145/TAMARIS). Methods An international, double-blind, placebo-controlled, randomised study composed 525 recruited from 170 sites worldwide who were had non-healing skin lesions was carried out to evaluate potential benefit repeated intramuscular administration NV1FGF. Randomisation stratified by country diabetic status. Results The mean age cohort 70 ± 10 years, included 70% males 53% patients. Fifty-four percent previous lower-extremity 22% minor index leg. In 94% patients, leg distal occlusive disease affecting arteries below knee. Statins prescribed 54% anti-platelet drugs 80%. Variation region origin resulted only demographic imbalance. Similarly, while status associated frequent history coronary artery disease, it little impact on haemodynamics vascular lesions. Conclusions Clinical anatomy ischaemic show variations findings this large will contribute our understanding process. is registered ClinicalTrials.gov , number NCT00566657.