Guerriero Frank P, Clark Robyn A, Miller Michelle, Delaney Christopher L
Department of Vascular and Endovascular Surgery, Flinders Medical Centre, Bedford Park, Adelaide, SA 5042, Australia.
College of Nursing and Health Sciences, Flinders University, Bedford Park, Adelaide, SA 5042, Australia.
Biomedicines. 2023 Feb 27;11(3):721. doi: 10.3390/biomedicines11030721.
Diabetes-related foot ulceration presents an increasing risk of lower limb amputation globally, driving the search for new treatment technologies. Our single-centre prospective observational study reports on the impact of bilayer biodegradable synthetic matrix technology (NovoSorb BTM) on the healing and amputation rates of a diabetic foot ulceration cohort. Consecutive patients with a diabetes-related foot ulceration treated with NovoSorb BTM, between December 2019 and October 2021, were followed for 12 months. Complete wound healing and amputation outcomes were observed. Amputation risk was stratified using the Wound, Ischaemia and foot Infection (WIfI) classification system. Study outcomes were compared with recently published meta-analysis data to evaluate the impact of the synthetic matrix. In total, 25 NovoSorb BTM applications to 23 wounds in 22 patients were observed. Complete wound healing was observed in 15 of the wounds, 3 retained chronic wounds, 3 required minor amputation and 2 required major limb amputation. Further, 12-month WIfI amputation risk analysis saw 18 patients stratified to WIfI stage 4, 4 to WIfI stage 3 and 1 to WIfI stage 1. Our observed 12-month major amputation rates were 11.1% ( = 2) for stage 4 and 0% for stages 3 and 1. Our early experience suggests that NovoSorb BTM is a safe and effective treatment for moderate to severe diabetes-related foot ulceration. While larger-scale data are required, NovoSorb BTM may represent a promising new addition to the armamentarium of clinicians, who strive to achieve limb salvage in this complex cohort of patients.
糖尿病相关足部溃疡在全球范围内导致下肢截肢的风险日益增加，这推动了对新治疗技术的探索。我们的单中心前瞻性观察研究报告了双层可生物降解合成基质技术（NovoSorb BTM）对糖尿病足部溃疡队列愈合率和截肢率的影响。对2019年12月至2021年10月期间接受NovoSorb BTM治疗的连续性糖尿病相关足部溃疡患者进行了12个月的随访。观察完全伤口愈合和截肢结局。使用伤口、缺血和足部感染（WIfI）分类系统对截肢风险进行分层。将研究结果与最近发表的荟萃分析数据进行比较，以评估合成基质的影响。总共观察到对22例患者的23处伤口应用了25次NovoSorb BTM。15处伤口实现了完全愈合，3处仍为慢性伤口，3处需要进行小截肢，2处需要进行大肢体截肢。此外，12个月的WIfI截肢风险分析显示，18例患者分层为WIfI 4期，4例为WIfI 3期，1例为WIfI 1期。我们观察到4期的12个月大截肢率为11.1%（n = 2），3期和1期为0%。我们的早期经验表明，NovoSorb BTM是治疗中度至重度糖尿病相关足部溃疡的一种安全有效的方法。虽然需要更大规模的数据，但NovoSorb BTM可能是临床医生武器库中一个有前景的新补充，临床医生致力于在这一复杂患者群体中实现保肢。
