Efficacy, Tolerability and Safety of Intramuscular Injections of PLX PAD for the Treatment of Sub… (NCT03006770) | Clinical Trial Compass
CompletedPhase 3
Efficacy, Tolerability and Safety of Intramuscular Injections of PLX PAD for the Treatment of Subjects With Critical Limb Ischemia (CLI) With Minor Tissue Loss Who Are Unsuitable for Revascularization
United States213 participantsStarted 2017-05-22
Plain-language summary
This will be a randomized, placebo-controlled, parallel group, multicenter, Phase III study.The study aims to evaluate the Efficacy, Tolerability and Safety of Intramuscular Injections of PLX PAD for the Treatment of Subjects with Critical Limb Ischemia (CLI) with Minor Tissue Loss (Rutherford Category 5) who are Unsuitable for Revascularization.
Who can participate
Age range45 Years – 99 Years
SexALL
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Inclusion criteria
✓. Adult male or female subjects between ages 45-99 years of age.
✓. CLI, with minor tissue loss up to the ankle level (Rutherford Category 5)
✓. Ankle pressure (AP) ≤70 mmHg or TP ≤50 mmHg in the index leg. (If a subject has ABI \>1.4 and TP is not measureable, inclusion may be based on TcPO2 ≤30 mmHg)
✓. Subject unsuitable for revascularization (by any method) in the index leg.
✓. Ischemic lesions in the index leg stable for at least 2 weeks.
✓. Ischemic ulcers in the index leg without tendon or bone exposure (unless secondary to a minor amputation).
✓. Under treatment for cardiovascular risk factors: hypertension, hyperlipidemia, diabetes, in accordance with applicable guidelines. Concomitant therapy with a statin and an anti-platelet agent for at least 2 weeks prior to randomization.
✓. Women of childbearing potential must have a negative serum pregnancy test at screening and must be willing to use at least one highly effective birth control method throughout the study.
Exclusion criteria
✕. Non-atherosclerotic PAD (e.g. Buerger's disease).
✕. CLI with major tissue loss (Rutherford Category 6) in either leg.
✕. Evidence of active infection (e.g., cellulitis, osteomyelitis).
. Subject having undergone surgical revascularization or major amputation less than 1 month prior to screening, or endovascular revascularization or minor amputation less than 2 weeks prior to screening.
✕. Planned or potential need for major/minor amputation or any revascularization within 1 month of study entry upon investigator's judgment.
✕. Aorto-iliac stenosis or common femoral artery stenosis ≥70%, or otherwise suspicion of inadequate inflow to the leg.
✕. Life expectancy of less than 6 months.
✕. Stroke or acute myocardial infarction/unstable angina within 3 months prior to screening.