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)
Overview
- Phase
- Phase 3
- Intervention
- Engensis (VM202)
- Conditions
- Foot Ulcer, Diabetic
- Sponsor
- Helixmith Co., Ltd.
- Enrollment
- 44
- Locations
- 22
- Primary Endpoint
- Proportion of Subjects With a Target Wound Closure by the 4-month Follow-up Visit
- Status
- Terminated
- Last Updated
- 6 months ago
Overview
Brief 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.
Detailed Description
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
Investigators
Eligibility Criteria
Inclusion Criteria
- •Male or female, between 18 and 80 years of age
- •Documented history of symptomatic PAD, with one or more of the following criteria satisfied:
- •ABI \>0.40 and ≤0.90 or \>1.4 (i.e., mild to severe PAD without critical limb ischemia) in target limb
- •TBI ≤0.7 in the target limb
- •Toe pressure of \<55 mmHg in the target limb
- •A history of lower extremity PAD 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, injectable medication, and/or insulin
- •No significant changes were anticipated in diabetes medication regimen
- •At Screening, the subject had one ulcer on the target foot that fulfilled all of the following criteria:
- •Present for ≥2 weeks and ≤1 year
Exclusion Criteria
- •Required revascularization in the target leg within 3 months of randomization
- •In the Investigator's assessment, required an amputation in the target leg within 3 months of randomization
- •Subjects with target foot ulcer with an etiology of vasculitis, pyoderma gangrenosum, necrobiosis lipoidica, hydrostatic pressure/venous insufficiency, any neoplasms (basalioma, Kaposi's sarcoma, squamous cell carcinoma, etc.), or due to a burn
- •The study ulcer increased or decreased by 50% or more at Baseline from Screening (as assessed by comparison of post-debridement photos taken at Screening and Day 0)
- •Evidence of active infection (e.g., cellulitis, osteomyelitis) or deep ulceration exposing bone or tendon in the foot planned for treatment
- •Any gangrene
- •Current fracture in the target foot
- •Target ulcer located on an active (hot) Charcot foot
- •Heart Failure with a New York Heart Association (NYHA) classification of III or IV
- •Body mass index (BMI) \>45 kg/m2 at Screening
Arms & Interventions
Active
Engensis (VM202) + standard of care
Intervention: Engensis (VM202)
Control
Placebo (VM202 Vehicle) + standard of care
Intervention: Placebo
Outcomes
Primary Outcomes
Proportion of Subjects With a Target Wound Closure by the 4-month Follow-up Visit
Time Frame: Days 0 to Month 4
Determine the proportion of subjects with a target Wound Closure from baseline to month 4 visit