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

• Status: Unknown status
• Trial end date: 2019-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This 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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Helixmith Co., Ltd.

Criteria

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