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

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

Study phase: III

Basic eligibility criteria:
Please contact the study coordinator for additional eligibility information.

Inclusion Criteria:

Documented symptomatic PAD, with one or more of the following criteria satisfied:
ABI > 0.40 and ? 0.90 (i.e., mild to severe PAD without critical limb ischemia) in target limb
TBI ? 0.7 in the target limb
Toe pressure of < 55 mm Hg in the target limb
A history of intermittent claudication with previous related intervention in a leg
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 that fulfills all of the following criteria:
Present for ? 2 weeks and ?1 year
Full- thickness and not involving bone, tendon, or capsule (probing to tendon or capsule)
No sign of infection or osteomyelitis
Ulcer must be 0.5 cm2 - 6.5 cm2 as measured at Screening Visit prior to debridement

Primary disease category: Diabetes & Endocrine System

Sponsor: ViroMed Co., Ltd.

Projected enrollment dates: June 2017 to June 2019

Official study title: A Phase III, Randomized, Double-blind, Placebo-controlled, MulticenterStudy to Assess the Safety and Efficacy of VM202 to Treat ChronicNonhealing Foot Ulcers in Diabetic Patients with Concomitant PeripheralArterial Disease (PAD)