A Phase III, Double-blind, Randomized, Placebo-controlled, Multicenter Study to Asses the Safety and Efficacy of VM202 to Treat Chronic Nonhealing Foot Ulcers in Diabetic Patients With Concomitant Peripheral Arterial Disease (PAD)
Brief SummaryThis study will assess the safety and efficacy of using gene therapy via intramuscular injections of the calf for patients with chronic non-healing foot ulcers.
Detailed DescriptionA 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 and Exclusion 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).
- Will require revascularization in the target leg within 3 months of randomization
- Unhealed prior amputation
- 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)
- More than one (1) ulcer on target foot
- 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
Please contact Karen DHuyvetter to learn more about where you can participate in this trial. Please use the contact form on the right side.