Continuous intrafemoral artery infusion of urokinase improves diabetic foot ulcers healing and decreases cardiovascular events in a long-term follow-up study.
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Abstract
Introduction: Diabetic foot ulcer (DFU) is a disabling complication of diabetes mellitus. Here, we attempted to assess whether long-term intrafemoral artery infusion of low-dose urokinase therapy improved DFUs and decreased cardiovascular events in patients with DFUs.
Research design and methods: This trial was a single-center, randomized, parallel study. A total of 195 patients with DFU were randomized to continuous intrafemoral thrombolysis or conventional therapy groups. The continuous intrafemoral thrombolysis group received continuous intrafemoral urokinase injection for 7 days, and conventional therapy just received wound debridement and dressing change. Then, a follow-up of average 6.5 years was performed.
Results: Compared with conventional therapy, at the first 1 month of intervention stage, the ulcers achieved a significant improvement in continuous intrafemoral thrombolysis group including a complete closure (72.4% vs 17.5%), an improved ulcer (27.6% vs 25.8%), unchanged or impaired ulcer (0% vs 56.7%). During the 6.5-year follow-up, for the primary outcome of ulcer closure rate, continuous intrafemoral thrombolysis therapy obtained a better complete healing rate (HR 3.42 (95% CI 2.35 to 4.98, p<0.0001)). For the secondary outcome of cardiovascular disease events, continuous intrafemoral thrombolysis therapy had a lower incidence of cardiovascular events (HR 0.50 (95% CI 0.34 to 0.74, p<0.0001)). Importantly, intrafemoral thrombolysis therapy decreased the incidence of cardiovascular death (HR 0.42 (95%CI 0.20 to 0.89, p=0.0241)). Additionally, continuous intrafemoral thrombolysis therapy improved local skin oxygenation and peripheral neuropathy as well as glycolipid metabolic profiles when compared with conventional therapy group (p<0.05).
Conclusions: Continuous intrafemoral thrombolysis therapy has a better therapeutic efficacy to improve DFUs and decrease cardiovascular events.
简介:糖尿病足溃疡(DFU)是一种致残性并发症:糖尿病足溃疡(DFU)是糖尿病的一种致残性并发症。在此,我们试图评估长期股动脉内输注低剂量尿激酶是否能改善糖尿病足溃疡并减少糖尿病足溃疡患者的心血管事件:该试验是一项单中心、随机、平行研究。共有195名DFU患者被随机分为连续股动脉内溶栓治疗组和常规治疗组。连续股骨内溶栓组接受连续7天的股骨内尿激酶注射,常规治疗组仅接受伤口清创和换药。然后,进行了平均 6.5 年的随访:结果:与传统疗法相比,在干预阶段的最初1个月,连续股动脉内溶栓治疗组的溃疡得到了显著改善,包括完全闭合(72.4% vs 17.5%)、溃疡改善(27.6% vs 25.8%)、溃疡无变化或受损(0% vs 56.7%)。在为期6.5年的随访中,就溃疡闭合率这一主要结果而言,连续股动脉内溶栓疗法获得了更好的完全愈合率(HR 3.42(95% CI 2.35至4.98,p结论:连续股骨内溶栓疗法在改善DFU和减少心血管事件方面具有更好的疗效:NCT01108120。
期刊介绍:
BMJ Open Diabetes Research & Care is an open access journal committed to publishing high-quality, basic and clinical research articles regarding type 1 and type 2 diabetes, and associated complications. Only original content will be accepted, and submissions are subject to rigorous peer review to ensure the publication of
high-quality — and evidence-based — original research articles.