Hepatocyte Growth Factor to Improve Functioning in PAD

PHASE2CompletedINTERVENTIONAL
Enrollment

39

Participants

Timeline

Start Date

January 1, 2018

Primary Completion Date

February 10, 2023

Study Completion Date

September 5, 2023

Conditions
Peripheral Artery Disease
Interventions
DRUG

VM202

"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."

OTHER

Placebo

"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."

Trial Locations (1)

60611

Northwestern University, Chicago

All Listed Sponsors
collaborator

National Institute on Aging (NIA)

NIH

collaborator

Helixmith Co., Ltd.

INDUSTRY

lead

Northwestern University

OTHER

NCT03363165 - Hepatocyte Growth Factor to Improve Functioning in PAD | Biotech Hunter | Biotech Hunter