The effect of insulin and sulodexide (Vessel Due F) on diabetic foot syndrome - Pilot study in elderly patients

To assess the efficacy of insulin plus sulodexide (a mixture of 80% heparin -like substances and 20% dermatan sulphate) on diabetic ulcers, and its inf luence on foot sl;in microcirculation and diabetic neuropathy. Two groups o f diabetic patients, suffering from severe neuropathy and ulceration, were randomly assigned to insulin (I) plus sulodexide (S) (n = 12) or insulin pl us placebo (P) (n=6) therapy, for 10 weeks. Laser Doppler assessment of foo t skin flow (LDF), at rest and 30 or 60 s after arterial occlusion, and ner ve conduction tests (sensorial evoked and motoric conduction potentials) ha ve been evaluated in both groups. Postischaemic flow was 2.5 times shorter in ulcerated vs. non-ulcerated feet in diabetic patients. A significant inc rease in flows after 30 and 60 s ischaemia was detected in both groups at t he end of therapy (IS group, ulcerated foot, LDF=60 s: from 99.1 +/- 14.3 t o 218.6 +/- 28.6 PU, P<.001. IP group=from 110.5 <plus/minus> 13.0 to 164.8 +/- 15.4 PU, P<.05). The length of reactive hyperaemia was higher in IS vs . If group (IS: from 30.3 <plus/minus> 2.9 to 43.9 +/- 2.2 s, P<.001; IP: f rom 28.7 <plus/minus> 3.0 to 33.3 +/- 3,3 s, ns). Ninety-two percent of ulc ers heals in a mean time of 46.4 days (IS group) vs. 83% and 63.0 days, res pectively, in IP group. Nerve conduction studies have not demonstrated with in- and between-group differences. Sulodexide and insulin improve the posti schaemic skin flow in ulcerated feet, without affecting nerve conduction te sts. The effect of sulodexide results additive to insulin; it is clinically relevant, in the view of the possibility of reducing the time needed to co mpletely heal ulcers. The ultimate validation of these preliminary results requires extensive trials. (C) 2001 Elsevier Science Inc. All rights reserv ed.