University of Greifswald, Germany.
Clin Hemorheol Microcirc. 2013 Jan 1;53(3):281-93. doi: 10.3233/CH-2012-1568.
OBJECTIVE: To investigate macro- and microperfusion during 14 days of treatment with a new 2-layer compression system (3M™ Coban™ 2 Lite), designed for patients with leg ulcer and concomitant peripheral arterial occlusive disease. METHODS: A single-centre, open-label, prospective pilot study was performed with 15 subjects suffering from peripheral arterial occlusive disease with an ankle brachial pressure index (ABPI) of 0.5-0.8, who volunteered to have their 'study leg' bandaged with the new system. Coincident leg ulcer or chronic venous disease was not mandatory. All subjects received the new compression system, which stayed in place from 1 up to 4 days according to scheduled study visits. The system was reapplied by study personnel at each clinical visit (days 1, 2, 3, 4, 7, 10 and 14). The study participation stopped after 14 days. At each clinical visit safety assessments were performed: measurement of acral pulsation to capture macroperfusion; laser Doppler fluxmetry to capture microperfusion; clinical signs of pressure related skin damage, hypoxia-related pain and sub-bandage pressure measurement. In addition, the leg volume was measured and a comfort questionnaire was completed. RESULTS: An average sub-bandage pressure in standing position of approximately 30 mmHg was measured at the B1 location immediately after bandage application. Laser Doppler fluxmetry demonstrated positive effects on microcirculation regarding vasomotion and respiratory reflux. No change of the cardiac signal appeared. For acrale pulsations a high intraindividual variability was found with no clear interference to the bandage application. No pressure-related skin damage or hypoxia-related pain was detected. CONCLUSION: After application of the new compression system in subjects with moderate PAOD, laser Doppler fluxmetry indicated significant improvements of the microcirculation. High variability and lack of correlation to clinical symptoms was found for the acral pulsation. The new compression system revealed a high grade of tolerability and a good safety profile.
目的：研究新的双层压缩系统（3M™ Coban™ 2 Lite）治疗 14 天期间的宏观和微观灌注情况，该系统专为腿部溃疡合并外周动脉阻塞性疾病的患者设计。
方法：进行了一项单中心、开放性、前瞻性试点研究，纳入了 15 名患有外周动脉阻塞性疾病的患者，其踝肱血压指数（ABI）为 0.5-0.8，自愿使用新系统包扎“研究腿”。同时患有腿部溃疡或慢性静脉疾病并非必要条件。所有患者均使用新的压缩系统，根据预定的研究访视，系统包扎时间为 1 至 4 天。每次临床访视（第 1、2、3、4、7、10 和 14 天），由研究人员重新包扎系统。每次临床访视均进行安全性评估：测量指端搏动以捕捉宏观灌注；激光多普勒流量metry 以捕捉微观灌注；压力相关皮肤损伤、缺氧相关疼痛和亚包扎压力的临床体征；此外，测量腿部容积并完成舒适度问卷。
结果：在包扎后立即测量，站立位 B1 位置的平均亚包扎压力约为 30mmHg。激光多普勒流量metry 显示，在血管运动和呼吸反流方面，对微循环有积极影响。未出现心脏信号变化。对于指端搏动，个体内变异性较大，对包扎应用无明显干扰。未发现压力相关皮肤损伤或缺氧相关疼痛。
结论：在中度 PAOD 患者中应用新的压缩系统后，激光多普勒流量metry 表明微循环有显著改善。指端搏动的变异性高，与临床症状缺乏相关性。新的压缩系统显示出良好的耐受性和安全性。
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