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 (TcPO), 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, TcPO was 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.

A Review of Antithrombotic Treatment in Critical Limb Ischemia After Endovascular Intervention

“…Batroxobin (5 IU/0.5 ml), 2 doses before and 4 doses post-procedure1241/267 (lesion)15.4n.s.Aspirin + batroxobin28/244 (lesion)11.4 Major amputation (above ankle amputation) Wang et al [34]RCTIntraluminal and/or subintimal angioplastyFemoro-popliteal and infra-poplitealAspirinAspirin (100 mg/day) from admission day to at least 12 months if no side effects. Batroxobin (5 IU/0.5 ml), 2 doses before and 4 doses post-procedure1211/6018.3n.s.Aspirin + batroxobin3/515.9Piaggesi et al [49]ObservationalPTA with or without stentingn.m.Aspirin or clopidogrelAspirin 100 mg/day, or clopidogrel 75 mg/day (if aspirin-intolerant). In case of stenting, patients received both indefinitely, alone, or + sulodexide 25 mg bid per os (upon discharge)63/2313.04n.s.Aspirin or clopidogrel + sulodexide3/2711.11Limb salvage and survival ratesWang et al [34]RCTIntraluminal and/or subintimal angioplastyFemoro-popliteal and infra-poplitealAspirinAspirin (100 mg/day) from admission day to at least 12 months if no side effects.…”

Sulodexide – unrealized potential in dermatology

“…Piaggesi et al evaluated efficacy of sulodexide as a supplementary therapy in patients with critical limb ischemia secondary to diabetes that underwent percutaneous endovascular angioplasty. In the group of patients who took sulodexide improvements in microcirculation functions and reduction of pain were confirmed; however, there were no differences in ulcer healing and frequency of amputations as compared with the control group [34]. Jin et al observed protective activity of sulodexide with regard to peripheral nerve damage caused by microvascular dysfunction in rats with induced diabetes [35].…”

“…oceniali skuteczność sulodeksydu jako terapii pomocniczej u chorych z krytycznym niedokrwieniem kończyn w przebiegu cukrzycy, poddanych przezskórnej angioplastyce wewnątrznaczyniowej. U chorych, u których stosowano sulodeksyd, stwierdzono poprawę funkcji mikrokrążenia i redukcję nasilenia bólu, natomiast nie stwierdzono różnic w gojeniu się owrzodzeń i częstości amputacji w porównaniu z grupą kontrolną [34]. Jin i wsp.…”

Sulodexide for Diabetic-Induced Disabilities: A Systematic Review and Meta-Analysis

“…Nineteen out of the 64 studies assessed for eligibility were excluded because they contained no quantitative data that was extractable [106][107][108][109][110][111][112][113][114], did not report any of the chosen endpoints [28,[115][116][117][118][119], their data were not stratified by pathology or treatment [120,121], data were reported without variance [122], or control data were only historical [123].…”