A Phase III, Double-blind, Randomized, Placebo-controlled, Multicenter Study to Assess the Safety and Efficacy of VM202 to Treat Chronic Nonhealing Foot Ulcers in Diabetic Patients With Concomitant Peripheral Arterial Disease (PAD)
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
Engensis (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 -Engensis (VM202) + standard of care - 200 patients
- Control - Placebo (VM202 Vehicle) + standard of care - 100 patients
Terminated | | Multisite
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Emerson Perin
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