Hospital-at-Home Department, Cruces University Hospital, Bizkaia, Spain.
Histocell S.L., Bizkaia Science and Technology Park, Derio, Bizkaia, Spain.
J Wound Care. 2023 Apr 2;32(4):238-246. doi: 10.12968/jowc.2023.32.4.238.
To evaluate the clinical efficacy of a new antioxidant therapy for the treatment of complex neuroischaemic diabetic foot ulcers (DFUs).
A prospective case series study has been conducted in patients with complex neuroischaemic DFUs after transmetatarsal amputation. DFUs were locally treated with an antioxidant dressing twice a week for the first two weeks, and then once a week until the end of the study or complete wound closure. Patients were followed-up for eight weeks and assessed weekly to analyse wound outcome. Primary outcomes were the wound closure ratio and percentage of granulation tissue; secondary outcomes were parameters related to wound management, namely, presence of non-viable tissue in the wound bed, levels of maceration and exudates, presence of erythema and pain.
A total of 20 patients were included with a mean baseline wound area of 20.4cm. At 8 weeks, the mean reduction in wound area was 88.1% (p<0.0001) and complete closure was observed in 33% of cases. In addition, there was a mean increase of 94.7% in granulation tissue in the wound bed (p<0.0001). Furthermore, the therapy was associated with a significant percentage reduction in wounds with non-viable tissue, good exudate management, and the maintenance of low levels of maceration, erythema and pain.
The new antioxidant therapy was associated with good clinical outcomes in large hard-to-heal neuroischaemic DFUs, with significant wound area reduction and granulation tissue formation. The therapy was also found to be safe and perform well from a practical perspective.
评估一种新型抗氧化疗法治疗复杂神经缺血性糖尿病足溃疡（DFU）的临床疗效。
对经跖骨截肢后发生复杂神经缺血性 DFU 的患者进行了前瞻性病例系列研究。DFU 局部用抗氧化敷料治疗，前两周每周两次，然后每周一次，直到研究结束或伤口完全闭合。患者接受 8 周的随访，并每周评估一次以分析伤口结局。主要结局是伤口闭合率和肉芽组织百分比；次要结局是与伤口管理相关的参数，即伤口床中无活力组织的存在、浸渍和渗出物的水平、红斑和疼痛的存在。
共纳入 20 例患者，平均基线伤口面积为 20.4cm²。8 周时，伤口面积平均减少 88.1%（p<0.0001），33%的病例完全闭合。此外，伤口床中肉芽组织平均增加 94.7%（p<0.0001）。此外，该治疗与伤口中无活力组织的百分比显著减少、良好的渗出物管理以及浸渍、红斑和疼痛的低水平维持有关。
新型抗氧化疗法在大型难以愈合的神经缺血性 DFU 中具有良好的临床疗效，可显著减少伤口面积并形成肉芽组织。该疗法在实际应用中也被发现是安全且表现良好的。
