Lázaro-Martínez José Luis, García-Álvarez Yolanda, Álvaro-Afonso Francisco Javier, García-Morales Esther, Sanz-Corbalán I, Molines-Barroso Raúl Juan
Diabetic Foot Unit, Universidad Complutense de Madrid, Instituto de Investigación Sanitaria del Hospital Clínico San Carlos (IdISSC), Madrid, Spain.
J Wound Care. 2019 Feb 2;28(2):104-109. doi: 10.12968/jowc.2019.28.2.104.
To describe the outcomes of a new product based on negatively charged polystyrene microspheres (NCM) technology, in non-responding diabetic foot ulcers (DFU).
A clinical case series of patients with a hard-to-heal DFU treated with NCM were recruited between March and June 2017 in a specialised diabetic foot unit. DFUs were treated daily with NCM over four weeks, although the health professional could decide to continue NCM treatment in some patients. Cases were followed up for 12 weeks. Wollina score (granulation, colour and consistency tissue), wound area (cm), percentage reduction and wound closure (%) were measured.
A total of 22 ulcers (19 patients) were included, of which three patients (five ulcers) were withdrawn due to adverse events: four infections and one necrosis. None were associated with the product. NCM treatment was completed in 17 ulcers (16 patients). The mean patient age was 61.53±9.57 years. At baseline, mean duration time of the DFU was 7.88±8.65 weeks, the median area was 5.35cm, the interquartile range (IQR) was 1.45 to 4.65cm and positive probe-to-bone test (PTB+) was recorded at 29.4%. After four weeks of treatment, an increase in Wollina score (3.65±2.12 to 5.69±1.18; p=0.000), a 62.2% reduction of the ulcer area (5.35 cm; IQR: 1.45 to 4.65cm) to 3.33cm (IQR: 0.25 to 1.70cm; p<0.001) and complete healing in 17.6% of ulcers was observed. The mean time of NCM treatment was 6.2±1.2 weeks. At 12 weeks, 100% achieved complete healing, including those ulcers with PTB+.
After NCM use, a reactivation of the healing process in non-responding wounds was observed, having a significant improvement in Wollina score as well as reduction of the wounds. Complete healing was achieved in all ulcers at 12 weeks, including PTB+.
描述一种基于带负电荷聚苯乙烯微球（NCM）技术的新产品在无反应性糖尿病足溃疡（DFU）中的治疗效果。
2017年3月至6月期间，在一个专门的糖尿病足治疗单元招募了一系列使用NCM治疗难愈合DFU的临床病例。DFU患者每天接受四周的NCM治疗，不过医疗专业人员可决定让部分患者继续接受NCM治疗。对病例进行了12周的随访。测量了沃利纳评分（肉芽组织、颜色和组织质地）、伤口面积（平方厘米）、缩小百分比和伤口闭合率（%）。
共纳入22处溃疡（19例患者），其中3例患者（5处溃疡）因不良事件退出：4例感染和1例坏死。均与该产品无关。17处溃疡（16例患者）完成了NCM治疗。患者平均年龄为61.53±9.57岁。基线时，DFU的平均持续时间为7.88±8.65周，中位面积为5.35平方厘米，四分位间距（IQR）为1.45至4.65平方厘米，阳性探针至骨试验（PTB+）记录为29.4%。治疗四周后，沃利纳评分增加（从3.65±2.12增至5.69±1.18；p = 0.000），溃疡面积缩小62.2%（从5.35平方厘米；IQR：1.45至4.65平方厘米）至3.33平方厘米（IQR：0.25至1.70平方厘米；p < 0.001），17.6%的溃疡实现完全愈合。NCM治疗的平均时间为6.2±1.2周。在12周时，100%实现完全愈合，包括PTB+的溃疡。
使用NCM后，观察到无反应性伤口的愈合过程重新激活，沃利纳评分显著改善，伤口缩小。在12周时所有溃疡均实现完全愈合，包括PTB+的溃疡。
