Department of Systems Medicine, University of Rome Tor Vergata, Rome, Italy.
Laboratoires URGO, Paris, France.
Int J Low Extrem Wounds. 2024 Dec;23(4):593-599. doi: 10.1177/15347346221087499. Epub 2022 Mar 15.
The study aimed to evaluate the effectiveness of the use of sucrose octasulfate impregnated dressing (TLC-NOSF [Technology Lipido-Colloid-Nano-OligoSaccharide Factor]) in the management of persons with neuro-ischaemic heel diabetic foot ulcers (DFUs). Consecutive patients who referred for an active non-infected neuro-ischaemic heel DFU belonging to grade IC (superficial) or IIC (deep to tendons, muscle or capsule) according to Texas University Classification were included. All patients were managed by a pre-set limb salvage protocol in the respect of International guidelines and the TLC-NOSF dressing was used as primary and specific dressing. Patients were evaluated any 2 to 4 weeks until wound healing or different outcomes. Primary outcome was the rate of complete wound healing after 24 weeks of follow-up. The secondary outcomes assessed the healing time, the rate of wound regression, the re-ulceration in the case of complete healing and the safety. Thirty patients were included. The mean age was 67 ± 11 years, 17 (56.7%) were male, all of them were affected by type 2 diabetes with a mean duration of 18 ± 7 years. Twenty patients (66.7%) showed deep ulcers (grade 2 of Texas University Classification); the mean TcPO2 at the inclusion was 42 ± 7 mm Hg. Twenty-two patients (73.3%) healed by Week 24. The mean time of healing was 84 ± 32 days, 2 (6.7%) patients had ulcer relapse after healing, 28 (93.3%) had wound regression >50%, 2 (6.7%) had mild infection, 1 (3.3%) reported major amputation. No serious adverse events related to TLC-NOSF dressing or local reactions were reported. This current study showed the potential benefit of sucrose octasulfate for treating neuro-ischaemic heel DFUs in addition to the standard of care.
本研究旨在评估蔗糖八硫酸酯浸渍敷料（TLC-NOSF [脂质胶体纳米寡糖因子技术]）在管理神经缺血性足跟糖尿病足溃疡（DFU）患者中的有效性。纳入连续就诊的、患有非感染性神经缺血性足跟 DFU 的患者，这些患者根据德克萨斯大学分类属于 IC 级（浅表）或 IIC 级（深至肌腱、肌肉或囊）。所有患者均按照国际指南的预设肢体保全方案进行管理，TLC-NOSF 敷料作为主要和特殊敷料使用。患者每 2 至 4 周评估一次，直至伤口愈合或出现不同结果。主要结局是在 24 周随访后完全愈合的比例。次要结局评估愈合时间、伤口消退率、完全愈合后的再溃疡率以及安全性。共纳入 30 例患者，平均年龄为 67±11 岁，17 例（56.7%）为男性，均患有 2 型糖尿病，平均病程为 18±7 年。20 例（66.7%）患者为深部溃疡（德克萨斯大学分类 2 级）；纳入时的平均 TcPO2 为 42±7mmHg。22 例（73.3%）患者在第 24 周愈合。平均愈合时间为 84±32 天，2 例（6.7%）患者愈合后溃疡复发，28 例（93.3%）患者伤口消退>50%，2 例（6.7%）患者出现轻度感染，1 例（3.3%）患者报告行大截肢。未报告与 TLC-NOSF 敷料相关的严重不良事件或局部反应。本研究表明，蔗糖八硫酸酯在治疗神经缺血性足跟 DFU 方面可能具有潜在益处，且不影响常规护理。
