Vol 3, No 1 (2002): Practical Diabetology
Other materials agreed with the Editors
Published online: 2001-12-06
The effect of insulin and sulodexide (Vessel Due F) on diabetic foot syndrome. Pilot study in elderly patients
Diabetologia Praktyczna 2002;3(1):49-56.
Abstract
To assess the efficacy of insulin plus sulodexide
(a mixture of 80% heparin-like substances and 20%
dermatan sulphate) on diabetic ulcers, and its influence
on foot skin microcirculation and diabetic neuropathy.
Two groups of diabetic patients, suffering
from severe neuropathy and ulceration, were randomly
assigned to insulin (I) plus sulodexide (S)
(n = 12) or insulin plus placebo (P) (n = 6) therapy,
for 10 weeks. Laser Doppler assessment of foot skin
flow (LDF), at rest and 30 or 60 s after arterial occlusion,
and nerve conduction tests (sensorial evoked
and motoric conduction potentials) have been evaluated
in both groups. Postischaemic flow was 2.5
times shorter in ulcerated vs. non-ulcerated feet in
diabetic patients. A significant increase in flows after
30 and 60 s ischaemia was detected in both groups
at the end of therapy (IS group, ulcerated foot, LDF
= 60 s: from 99.1 ± 14.3 to 218.6 ± 28.6 PU, P <
0.001. IP group = from 110.5 ± 13.0 to 164.8 ± 15.4
PU, P < 0.05). The length of reactive hyperaemia was
higher in IS vs. IP group (IS: from 30.3 ± 2.9 to 43.9
± 2.2 s, P < 0.001; IP: from 28.7 ± 3.0 to 33.3 ± 3.3 s,
ns). Ninety-two percent of ulcers heals in a mean time
of 46.4 days (IS group) vs. 83% and 63.0 days, respectively,
in IP group. Nerve conduction studies have
not demonstrated within- and between-group differences.
Sulodexide and insulin improve the postischaemic
skin flow in ulcerated feet, without affecting
nerve conduction tests. The effect of sulodexide results
additive to insulin; it is clinically relevant, in the
view of the possibility of reducing the time needed
to completely heal ulcers. The ultimate validation of
these preliminary results requires extensive trials.
Keywords: diabetic foot syndromeperipheral diabetic neuropathyglycosaminoglycans