Institut für Forschung in der Operativen Medizin (IFOM), University of Witten/Herdecke, Ostmerheimerstraße 200 Haus 38, 51109, Köln, Germany.
J Foot Ankle Res. 2022 Sep 30;15(1):72. doi: 10.1186/s13047-022-00569-w.
Diabetic foot ulcers not only have a negative impact on patient mortality, morbidity and quality of life, but also require high resource utilization to achieve complete wound healing. The aim of this evaluation was to compare resource utilization of negative pressure wound therapy (NPWT) and standard moist wound care (SMWC) for diabetic foot wounds after amputation, surgical debridement or wound cleansing.
The multicenter clinical DiaFu study enrolled 368 adults with diabetic foot ulcers between December 23, 2011 and October 21, 2014. Patients were randomly assigned to NPWT and SMWC. Evaluation of direct resource use comprised inpatient and outpatient treatment time, and personnel and material for wound treatment within 16 weeks. This resource use analysis was primarily based on the per protocol population (NPWT 44; SMWC 110).
Treatment duration was 16 days shorter with NPWT (mean (SD) 82.8 (31.6), SMWC 98.8 (24.6); U test, p = 0.001) with 14.9 days shorter outpatient treatment (mean (SD) NPWT 68.3 (31.1), SMWC 83.2 (29.7)). The number of dressing changes per study participant was lower with NPWT (mean (SD) 35.1 (18.6), SMWC (42.9 (21.4); U test, p = 0.067). Time per dressing change was significantly lower with SMWC (mean (SD) 19.7 (12.8), NPWT (16.5 (8.2) minutes; U test, p < < 0.0001). Time for surgical debridements per study participant was 23.3 minutes shorter with NPWT (mean (SD) 20.5 (20.5), SMWC (43.8 (46.7); U test, p = 0.395).
Resource use was lower for NPWT, which may be an efficient treatment alternative to SMWC for diabetic foot wounds, to be demonstrated in subsequent cost analyses.
clinicaltrials.gov NCT01480362 on November 28, 2011.
糖尿病足溃疡不仅对患者的死亡率、发病率和生活质量有负面影响，而且为了实现完全愈合，还需要大量的资源。本评估的目的是比较负压伤口治疗（NPWT）和标准湿性伤口护理（SMWC）在糖尿病足溃疡截肢、清创或伤口清洗后的资源利用情况。
多中心临床 DiaFu 研究于 2011 年 12 月 23 日至 2014 年 10 月 21 日期间招募了 368 名糖尿病足溃疡成年患者。患者被随机分配到 NPWT 和 SMWC 组。直接资源利用的评估包括 16 周内的住院和门诊治疗时间以及伤口治疗的人员和材料。本资源利用分析主要基于方案人群（NPWT 44 例；SMWC 110 例）。
NPWT 的治疗时间缩短了 16 天（平均（SD）82.8（31.6），SMWC 98.8（24.6）；U 检验，p=0.001），门诊治疗时间缩短了 14.9 天（平均（SD）NPWT 68.3（31.1），SMWC 83.2（29.7））。每位研究参与者的换敷料次数较低（NPWT 平均（SD）35.1（18.6），SMWC（42.9（21.4）；U 检验，p=0.067）。每次换敷料的时间明显较短，SMWC （平均（SD）19.7（12.8），NPWT（16.5（8.2）分钟；U 检验，p<<0.0001）。每位研究参与者的手术清创时间缩短了 23.3 分钟，NPWT（平均（SD）20.5（20.5），SMWC（43.8（46.7）；U 检验，p=0.395）。
NPWT 的资源利用率较低，可能是糖尿病足溃疡的一种有效的替代治疗方法，在随后的成本分析中需要进一步验证。
clinicaltrials.gov NCT01480362 于 2011 年 11 月 28 日。
