Safety and Efficacy Study of VM202 in the Treatment of Chronic Non-Healing Foot Ulcers

A phase III, randomized, double-blind, placebo-controlled, multicenter, 7-month study
designed to assess the safety and efficacy of intramuscular (IM) injections in the calf of
VM202 in patients with chronic nonhealing foot ulcers. Three hundred patients will be
randomized in a 2:1 ratio of VM202 or placebo injections:

- Active -VM202 + standard of care - 200 patients

- Control - Placebo (VM202 Vehicle) + standard of care - 100 patients

Inclusion Criteria:

- Documented symptomatic PAD

- Documented history of Type I or II diabetes with current treatment control (HbA1c of ≤
12.0% at Screening) and currently on oral medication and / or insulin

- No significant changes anticipated in diabetes medication regimen

- At Screening, subject has one ulcer on the target foot

- Subjects will undergo protocol-defined standardized wound care during screening (for
two weeks or longer).

Exclusion Criteria:

- Will require revascularization in the target leg within 3 months of randomization

- In the investigator's assessment, will require an amputation in the target leg within
3 months of randomization

- Subject diagnosed with critical limb ischemia (CLI; Rutherford score ≥ 4)

- Evidence of active infection (e.g., cellulitis, osteomyelitis) or deep ulceration
exposing bone or tendon in the foot planned for treatment

- Current fracture in the target foot

- Heart Failure with a New York Heart Association (NYHA) classification of III or IV;

- Body mass index (BMI) > 45 kg/m2 at Screening

- Unstable angina