evaluation of the efficacy of combined therapy of patients with diabetic foot syndrome using Αlpha-lipoic acid preparations and low-molecular-weight heparin

Abstract

In this study we have investigated the efficacy of combination of alpha-lipoic acid (ALA) and bemiparin compared to baseline hypoglycemic therpay or additional monotherapy with ALA in patients with diabetic foot syndrome. The study involved 82 patients. Control group included 14 patients who received only hypoglycemic therapy. 37 patients made-up first study group (SG-1) treated with alpha-lipoic acid only in additional to hypoglycemic therapy, first parenterally, then per os. In the second study group (SG-2, 31 patients) we administered combination of ALA and bemiparin. Efficacy criteria were level of transcutaneous partial pressure of oxygen (PtcO2) on the back of the foot and average rating by scale of neuropathy symptoms — NSS. They were determined three times: before treatment, after parenteral administration of ALA and injection of bemiparin (average 12–16 days) and after oral administration of ALA (approximately in 50 days). In patients from SG-1, PtcO2 growth in the first stage has been slower (from 33.11 ± 7.21 mmHg to 36.19 ± 6.45 mmHg) and statistically insignificant (p = 0.054), while in the combination therapy group oxygenation level increased from 30.74 ± 8.50 mmHg up to 39.94 ± 8.14 mmHg, which was significantly better that indicator in the SG-1 (p < 0.05), and baseline (p < 0.01). In the SG-1, PtcO2 at the end of the whole course of treatment has reached 37.65 ± 5.44 mmHg, which was significantly better compared to baseline (p < 0.05). In the SG-2, PtcO2 on the 50th day was 41.61 ± 7.74 mmHg, it is significantly better result as compared to the SG-1 (p < 0.05) and baseline (p < 0.01). In addition, the combination therapy significantly reduced the severity of neuropathy on NSS: from 6.26 ± 1.19 to 3.74 ± 0.62 compared with the control group (from 6.14 ± 0.99 to 5.43 ± 0.90). Also we observed a somewhat better dynamics by NSS compared with ALA monotherapy group, but it did not reach statistical significance.