50 research outputs found

    Pilot study of the safety and efficacy of angiogenic therapy in diabetic foot syndrome

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    BACKGROUND: The syndrome of diabetic foot remains the main cause of non-traumatic amputation of the lower extremity in the world. Even with the provision of comprehensive medical care in the conditions of a specialized center, 10-15% of patients do not succeed in healing the ulcerative defect due to the ischemic component. AIMS: The objective of this study is evaluation of safety and efficacy of pl-VEGF165 transfer in patients with neuroischemic type of diabetic foot syndrome. METHODS: The pilot study included 35 diabetic patients with neuroischemic foot ulcers (Wagner stage 1-2) who were not candidates for revascularization procedures (NCT02538705). The patients were closely monitored after repeated pl-VEGF165 intramuscular gene transfer (2,4 mg) at 1, 3, and 6 months after treatment. The primary efficacy endpoint was the surface area of the ulcers (sq.cm), the secondary endpoints were transcutaneous oxygen tension (Tcp02), ankle-brachial index (ABI), neuropathy disability score (NDS), neuropathy symptoms score (NSS), and Michigan neuropathy screening instrument (MNSI). Adverse events were monitored throughout the study. RESULTS: The use of pl-VEGF165 as part of complex treatment allowed to achieve wound healing in 65,7% of patients with chronic ulcerative defects, the safety of the target limb was 84%. Carrying out therapeutic angiogenesis as a part of the combined therapy ensured a reduction in the average area of the resistant to treatment defects from 3.6 [1.0; 7.05] cm2 to 0.0 [0.0;2.0] cm2 (p=0,001), which correlated with an increase in the TcPo2 index by 15% from 35 [29.5; 40.5] to 40.5 [36.0; 46.5] mm Hg (p= p=0,005) and in the ABI by 16% from 0.96 [0.82;1.08] to 1.11 [0.85; 1.24] (p=0,062). The decrease in the signs of diabetic neuropathy was determined - the scores of NSS scales and VAT decreased from 6,5 [5.75; 8.0) to 6.0 [5.25; 7.0] (p=0,004) and from 9.0 [8.0; 13.5] to 8.0 [7.0; 12.7] (p=0,001), respectively. No adverse effects associated with the use of pl-VEGF165 were recorded. CONCLUSIONS: Thus, preliminary results of the pilot study show that the use of pl-VEGF165 gene transfer in combination therapy allows for complete healing of neuroischemic diabetic foot ulcers in the majority of patients

    Clinical effectiveness of bioflavonoids in the treatment of secondary lower limb lymphedema

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    AIM: This study aimed to investigate the effectiveness of the application of a combination of the preparation of micronized purified flavonoid fraction (MPFF) and elastic compression in patients with acquired lymphostasis.&#x0D; MATERIALS AND METHODS: Sixty patients with stage II secondary lower limb lymphedema according to М. Foeldi were included. The patients were divided into two groups through randomization with the envelope method. The first group (n = 30) was subjected to a conservative treatment (MPFF, 1000 mg/day) coupled with elastic compression (3rd class compression stockings). The second group was given compressive therapy (third-class compression stockings). The patients were physically examined through the measurement of the circumference of the limb at different levels.&#x0D; RESULTS: In the first group, the circumference of the lower third of the shin decreased by 8.15% (p = 0.005) after 1 month and by the end of treatment by 10.6% (p 0.001), of the middle third of shin by 3.15% (p = 0.001) and 4.78% (p 0.001), and of the upper thirdby 4.08% (p 0.001) and 5.99% (p 0.001). By the end of the observation period (3 months), the circumference of the lower third of the shin in the second group (29.68 4.67 cm) was significantly greater than that in the first group (26.65 2.92 cm, p = 0.035). No adverse reactions were observed in the MPFF group.&#x0D; CONCLUSIONS: The volume of the lower limbs of patients with acquired lymphedema decreased after using a combination of MPFF and elastic compression to a larger extent than after the isolated use of elastic compression. Patients taking MPFF had a positive clinical effect without adverse reactions. Therefore, MPFF could be used in the pharmacotherapy of secondary lymphedema of the lower limbs.</jats:p

    Potentials of Using Allografts in Surgical Treatment of Popliteal Artery Aneurysms

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    BACKGROUND: The gold standard in reconstructive surgical operations on the infrainguinal arteries is the autovenous conduit from the great saphenous vein. However, in the absence of a suitable autovein, difficulties are encountered in the selection of a suitable material for reconstruction. The use of a synthetic prosthesis as an alternative in the knee joint region is not always possible, especially in the distal position. Unsatisfactory results of using such materials dictate the need to choose a suitable graft. The paper describes two case experiences of using allografts from a deceased donor for the surgical treatment of popliteal artery aneurysms. The cases present their potential for use in emergency clinical situations. In the first case, the patient had previously undergone phlebectomy. In the second case, the saphenous veins of the lower limbs had scattered branches and insufficient diameter for reconstruction.&#x0D; CONCLUSION: The described cases presented the possible effective use of allografts from a deceased donor in patients with true popliteal artery aneurysms.</jats:p

    RISK OF PULMONARY EMBOLISM ASSOCIATED WITH SUPERFICIAL VEIN THROMBOPHLEBITIS

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    This article represents the evaluation of risk of pulmonary embolism associated with superficial vein thrombophlebitis based on observations in more than 500 patients.We found that acute thrombophlebitis was associated with varicose veins stage C3 to C6 of the CEAP classification in 30% cases and varicose veins with insignificant valve insufficiency verified by duplex ultrasound scan in 35% patients. During the surgical operations we found thrombosis extending to the saphenofemoral junction in 90 patients (17.8%) while in 35 patients the thrombi were found in femoral vein. Thus 24.7% of patients were at high risk of pulmonary thromboembolism.</jats:p

    Study of the antioxidant status in patients with secondary lymphedema of the lower extremities under conservative treatment

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    Aim. To assess the antioxidant status in patients with secondary lymphedema of the lower extremities who undergo different types of conservative treatment.&#x0D; Methods. The study included 90 patients with secondary lymphedema of the lower extremities and 30 healthy volunteers. Group 1 participants (n=30) received compression therapy and Vitamin E at a dose of 400 IU/day, group 2 participants (n=30) compression therapy and a micronized purified flavonoid fraction 1000 mg/day, group 3 (n=30) compression therapy alone. Group 4 (n=30) comprised healthy volunteers. The level of malondialdehyde, the activity of superoxide dismutase, glutathione peroxidase, catalase, and the level of non-protein thiols (SH-groups) were determined at inclusion in the study and then after 1 and 3 months.&#x0D; Results. In patients with secondary lymphedema, the initial level of glutathione peroxidase was higher by 768.22%, catalase by 420.5%, malondialdehyde by 60%, and the level of SH-groups was lower by 65,71% compared with the group of volunteers. In the first group, there was a significant decrease of 36.1% in the level of superoxide dismutase and a significant increase of 89.9% in the level of glutathione peroxidase at the end of therapy when compared with the level after 1 month. In the second group, catalase level significantly increased by 33.3%, superoxide dismutase by 17.6%, and glutathione peroxidase by 61.3% compared to baseline values. The biochemical indicators of the endothelium significantly increased when using a combination of micronized purified flavonoid fraction and elastic compression in comparison with elastic compression alone and a combination with Vitamin E. In the third group, there were no significant differences in the levels of biochemical indicators of endothelial function.&#x0D; Conclusion. Increased formation of lipid peroxidation products along with a decrease in the activity of antioxidant systems was revealed in patients with lower extremity secondary lymphedema compared with healthy volunteers; the most effective therapy aimed at correcting endothelial cell dysfunction is the use of micronized purified flavonoid fraction and elastic compression.</jats:p
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