At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Hepatocyte Growth Factor to Improve Functioning in Peripheral Artery Disease: The HI-PAD Study
In Brief
A Phase 2 clinical trial evaluating VM202 and Placebo for Peripheral Artery Disease. Completed, enrolled 39 participants across 1 site.
Detailed Summary
HI-PAD is a placebo controlled double-blind randomized pilot clinical trial to determine whether VM202 may improve walking ability in people with lower extremity peripheral artery disease (PAD).
Study Details
Timeline
Interventions
Participants randomized to VM202 will receive calf muscle injections of VM202 to each leg with evidence of PAD. Injections of VM202 are administered by a physician in a double-blinded fashion after randomization on Day 0, Day 14, Day 28, and Day 42, for a total of four treatment days. Therefore, participants randomized to VM202 will receive 4 mgs of VM202 in each calf muscle on each treatment day. Injections are placed beginning 2 cm below the popliteal crease, and are administered in a pre-designed sequence and pattern, at a measured distance 2 cm apart. Note: Participants who have a evidence of PAD in only one leg will only receive injections in the leg with evidence of PAD.
Participants randomized to placebo will receive calf muscle injections of placebo (the excipient buffer formulation minus the VM202) to each leg with evidence of PAD. Injections of placebo are administered by a physician in a double-blinded fashion after randomization on Day 0, Day 14, Day 28, and Day 42, for a total of four treatment days. Placebo appears identical to the VM202 study drug and is administered in a pattern on the calf identical to that of the VM202 injections. Note: Participants who have a evidence of PAD in only one leg will only receive injections in the leg with evidence of PAD.