title: Sulodexide as Adjunctive Therapy in Diabetic Foot Patients With Critical Limb Ischemia Treated With Percutaneous Transluminal Angioplasty.
abstract: We evaluated the safety and efficacy of sulodexide, a biocompound of glycosamin-glicans, as adjunct medical therapy to percutaneous transluminal angioplasty (PTA) in diabetes mellitus (DM) patients with critical limb ischemia (CLI). We studied 27 consecutive DM patients with CLI successfully subjected to PTA who, on top of standard antiplatelet therapy, received sulodexide 25 mg bid, and were followed-up for 24 weeks, monitoring adverse events, transcutaneous oxygen tension (TcPO2), ankle-brachial pressure index, pain, and ulcer dimension. At the end of follow-up, ulcer healing, amputation rates, and cardiovascular risk profile of patients were evaluated. Patients were compared with a historical superimposable control group that was treated for the same indications in the same way as the study group, except for sulodexide inception. No differences in ulcer healing and amputation rates were found at the end of follow-up between the groups. In the study group, TcPO2was significantly (P < .05) higher at the end of follow-up, and pain intensity was reduced more rapidly. Plasma fibrinogen and plasma creatinine concentration were significantly (P < .05) reduced in study group at the end of follow-up. No differences in adverse events were observed between the groups during follow-up. Our data suggest that sulodexide administration after PTA, on top of antiplatelet therapy, may improve the outcome of PTA in DM patients with CLI by improving microcirculatory function.
authors.affiliation: Diabetic Foot Section, Department of Medicine, Azienda Ospedaliero-Universitaria Pisana, Via Paradisa, Pisa, Italy piaggesi@immr.med.unipi.it.
authors.forename: Alberto
authors.initials: A
authors.lastname: Piaggesi
authors.affiliation: Diabetic Foot Section, Department of Medicine, Azienda Ospedaliero-Universitaria Pisana, Via Paradisa, Pisa, Italy.
authors.forename: Lorenza
authors.initials: L
authors.lastname: Abbruzzese
authors.affiliation: Diabetic Foot Section, Department of Medicine, Azienda Ospedaliero-Universitaria Pisana, Via Paradisa, Pisa, Italy.
authors.forename: Chiara
authors.initials: C
authors.lastname: Mattaliano
authors.affiliation: Interventional Radiology Section, University Hospital of Pisa, Pisa, Italy.
authors.forename: Irene
authors.initials: I
authors.lastname: Bargellini
authors.affiliation: Interventional Radiology Section, University Hospital of Pisa, Pisa, Italy.
authors.forename: Antonello
authors.initials: A
authors.lastname: Cicorelli
authors.affiliation: Diabetic Foot Section, Department of Medicine, Azienda Ospedaliero-Universitaria Pisana, Via Paradisa, Pisa, Italy.
authors.forename: Elisabetta
authors.initials: E
authors.lastname: Iacopi
authors.affiliation: Interventional Radiology Section, University Hospital of Pisa, Pisa, Italy.
authors.forename: Alessandro
authors.initials: A
authors.lastname: Lunardi
authors.affiliation: Diabetic Foot Section, Department of Medicine, Azienda Ospedaliero-Universitaria Pisana, Via Paradisa, Pisa, Italy.
authors.forename: Alberto
authors.initials: A
authors.lastname: Coppelli
authors.affiliation: Diabetic Foot Section, Department of Medicine, Azienda Ospedaliero-Universitaria Pisana, Via Paradisa, Pisa, Italy.
authors.forename: Chiara
authors.initials: C
authors.lastname: Goretti
authors.affiliation: Interventional Radiology Section, University Hospital of Pisa, Pisa, Italy.
authors.forename: Roberto
authors.initials: R
authors.lastname: Cioni
keywords: critical limb ischemia; diabetic foot; follow-up; medical therapy; revascularization