Safety and Efficacy Study of Engensis (VM202) in the Treatment of Chronic Non-Healing Foot Ulcers (NCT02563522) | Clinical Trial Compass
TerminatedPhase 3
Safety and Efficacy Study of Engensis (VM202) in the Treatment of Chronic Non-Healing Foot Ulcers
Stopped: Low enrollment
United States44 participantsStarted 2017-06-27
Plain-language 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.
Who can participate
Age range18 Years – 80 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Exclusion criteria
✕. Capable of understanding and complying with the protocol and signed the informed consent document prior to being subjected to any study related procedures
✕. If female of childbearing potential, negative urine pregnancy test at Screening and used an acceptable method of birth control during the study
✕. 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
What they're measuring
1
Proportion of Subjects With a Target Wound Closure by the 4-month Follow-up Visit
✕. 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