Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Sanofi
Screening period of 30 days before dosing. Patients receive a single administration or repeated (2) administrations (with a 2-week interval) of NV1FGF. Patients are then followed for a period of 6 months
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Severe PAOD defined as Rutherford's Grade II, category 4 or Grade III, category 5 and 6
Pain at rest for at least 2 weeks duration and/or trophic lesions for at least the previous 14 days with no signs of healing (no reduction in ulcer size or depth)
Objective evidence of peripheral vascular disease (resting Ankle Brachial Index \< 0.4 and/or resting Toe Brachial Index \< 0.3 and/or metatarsal Peripheral Vascular Resistance flat or barely pulsatile in the diseased limb on 2 consecutive examinations performed at least 2 weeks apart)
Angiographic demonstration of total occlusion of the affected limb of one or more of the iliac, superficial femoral, popliteal and/or one or more infrapopliteal arteries
Poor candidate for surgical intervention or revascularization procedures (no tibial artery incontinuity as defined from mid-leg distance from the foot and no autologous tissue available)
You may not be if
Previous or current history of malignant disease. Patients who had successful tumor resection more than 10 years prior to inclusion into the study and had no recurrence and patients who had curatively resected basal/squamous cancer of the skin were allowed for inclusion
Abnormal chest X-ray with suspected malignant tumor presence
Positive stool hemoccult (expect if due to hemorrhoids)
Positive Prostate Specific Antigen for men with suspected malignant tumor presence
Abnormal mammography for women with suspected malignant tumor presence
Papanicolaou smear (for women) of Class IV or Class V characterization
Proliferative retinopathy
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
