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
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.
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
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