In an attempt to avert impending, primary amputation, an 85-year-old woman
with chronic critical leg ischemia was enrolled in an experimental protocol
to induce therapeutic angiogenesis. Treatment consisted of six consecutive
, weekly intravenous infusions of recombinant basic fibroblast growth facto
r (bFGF). Angiographic evaluation was performed before and after therapy. T
he patient's clinical response was monitored through serial measurements of
the ankle/brachial index and by repetitive assessment of limb flow by merc
ury strain-gauge plethysmography.
A beneficial clinical response was detectable by week 4 of therapy, which w
as characterized by an improved walking distance, relief of ischemic pain,
a marked reduction in analgesic consumption, and healing of persistent, unr
esponsive, painful inflammation of the hallux, The clinical improvement was
sustained throughout the remaining weeks of therapy and follow-up evaluati
on. Plethysmography documented improved blood flow; specifically, the augme
ntation of digital flow was sustained and correlated with the marked improv
ement in the patient's clinical status.