Overall, 8.9% patients (28/314) enrolled in the study experienced
anamputation/bone resection.Amputation/bone resection occurred
in 5.5% (9/163) of HFDS and 12.6% (19/151) of control-treated patients
from the ITT population (P =.031; Table 1). In the population of
patients whose ulcers were greater than 6 weeks’ duration, 7.8%
(19/245) experienced an amputation/bone resection AE; amputation/
bone resection occurred in 4.6% (6/130) of patients who received
HFDSand in 11.3% (13/115)whoreceived control treatment (P=.058).