RESEARCH DESIGN AND
METHODS — This prospective study
was performed in two teaching hospitals
(Rome and Milan). Only patients with
previous foot ulceration and those considered
to be at high risk of foot ulceration
(9) were included in the study. They were
randomized to wear either their ordinary
nontherapeutic shoes or therapeutic
shoes with custom-molded insoles. Initially,
patients fulfilled the following criteria:
1) absence of ulceration, 2) absence
of previous minor or major amputations,
and 3) absence of major foot deformities
such as Charcot joints. All patients received
the same educational guidelines
on foot care and general information on
the importance of appropriate footwear
(i.e., proper size, durability, and sole).
The patients in the control group were
free to wear ordinary shoes unless clearly
dangerous. The same follow-up protocol
was applied to both groups. Use of the
specific footwear was rated as infrequent,
occasional, frequent, or continuous; and
the state of the shoes was assessed after 6
months, when a second pair was given.
The patients were considered to have had
an ulcer relapse either when a new ulcer
appeared in the site of the previous one or
when a new foot ulcer appeared in a different
area.