NCT02144610.
Trial name or title | Efficacy and safety of AMG0001 in subjects with critical limb ischemia (AGILITY) |
Methods | Phase III randomised parallel‐assignment quadruple‐blinded placebo‐controlled study |
Participants | Participants with critical limb ischaemia |
Interventions | HGF plasmid (AMG0001) or placebo |
Outcomes | Time to major amputation, Major amputation and revascularisation, Complete ulcer healing, Ischaemic rest pain, Quality of life, Incident stroke and myocardial infarction, Primary bypass graft patency |
Starting date | May 2014 |
Contact information | Richard J Powell; Dartmouth‐Hitchcock Medical Center |
Notes |
HGF: hepatocyte growth factor. PAD: peripheral arterial disease.