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).
The HI-PAD study will randomize 39 people age 55 and older with PAD who do not have critical limb ischemia. The primary outcome is change in the six-minute walk distance at 6-month follow-up after the first study drug injection. A secondary outcome in change in six-minute walk distance at 3-month follow-up. Additional secondary outcomes are pain-free and maximal treadmill walking distance, calf biopsy measures of skeletal muscle regeneration, capillary density, and autophagy, and MRI-measured calf muscle perfusion at three-month follow-up. Investigators will also measure change in six-minute walk distance at 12-month follow-up.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
39
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.
Northwestern University
Chicago, Illinois, United States
Six-minute Walk Distance
Participants walking up and down a 100 foot hallway for six minutes following a standardized protocol. The goal is for them to walk as far as possible in six minutes
Time frame: Change from baseline to six-month follow-up in six-minute walk distance
Maximal Treadmill Walking Time
A Gardner or Modified Gardner treadmill exercise protocol will be used
Time frame: Change from baseline to three-month follow-up
Calf Muscle Perfusion
Calf muscle perfusion is measured by Magnetic Resonance Imaging (MRI) Unit of measure is ml/minute per 100 gms tissue
Time frame: Change from baseline to three-month follow-up
Calf Muscle Biopsy Biochemical Measures (Satellite Cells - Total SCs/100 Fibers)
A skeletal muscle sample will be obtained from the calf muscle. The outcome is the number of satellite cells per 100 muscle fibers
Time frame: Change from baseline to three-month follow-up
Walking Impairment Questionnaire - Distance Score
The well validated Walking Impairment Questionnaire will be used to measure patient- perceived walking performance. The WIQ is scored from 0-100, with 100 being the best score. We will use distance and speed sub-components separately.
Time frame: Change from baseline to three-month follow-up
The Short-Form-36 Physical Functioning Score
This well validated quality of life measure will be used to assess changes in patient perceived quality of life. The SF-36 is scored from 0-100, with 100 being the best score.
Time frame: Change from baseline to three-month follow-up
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The Short-Form-36 Physical Functioning Score
This well validated quality of life measure will be used to assess changes in patient perceived quality of life. Scored on a 0-100 scale, where 100- is best.
Time frame: Change from baseline to six-month follow-up
Walking Impairment Questionnaire - Distance Score
The well validated Walking Impairment Questionnaire will be used to measure patient- perceived walking performance.
Time frame: Change from baseline to six-month follow-up
Six-minute Walk Distance
Participants walking up and down a 100 foot hallway for six minutes following a standardized protocol. The goal is for them to walk as far as possible in six minutes
Time frame: Change in six-minute walk distance from baseline to three-month follow-up
Pain-free Treadmill Walking Time
A Gardner or Modified Gardner treadmill exercise protocol will be used
Time frame: Change from baseline to three-month follow-up