Type 2 diabetes (T2D) in developed countries have a prevalence of 11% with diabetic foot infections as the most common cause of hospitalization and amputation. To achieve healing of the diabetic foot ulcer wounds, appropriate dressings are essential and their effectiveness can be enhanced with nanoparticles, nevertheless ideal combinations of dressing composition and nanodrugs require further testing in humans. We have developed a calcium alginate dressings with ZnO nanoparticles (CAZnODs) for the treatment of diabetic foot ulcers in human patients. To test the efficacy of CAZnODs we designed a randomized controlled clinical experiment on 26 T2D patients with foot ulcers. The patients were randomized into two groups: G1 treatment with calcium alginate with NPs (G1; n = 16), and group 2 received the treatment without NPs (G2, n = 10). The bandage change was performed every 48 h The duration of the protocol was established at 10 weeks. Here, we report healing was achieved in patients, with 75% wound closure in G1 under treatment with NPs of calcium alginate versus 71% in G2 (calcium alginate without NPs) (p = 0.011). The average healing time was 48 days in G1 and 72 days in G2. Our data shows that CAZnODs were well tolerated and did not interfere with the wound healing process. The final wound area and time of healing support the hypothesis that the use of calcium alginate dressings with nanoparticles may induce better tissue regeneration while avoiding T2D complications such as secondary infections.

在发达国家，2 型糖尿病 (T2D) 的患病率为 11%，其中糖尿病足感染是住院和截肢的最常见原因。为了实现糖尿病足溃疡伤口的愈合，适当的敷料是必不可少的，并且它们的有效性可以通过纳米粒子来增强，然而，敷料组合物和纳米药物的理想组合还需要在人体中进行进一步的测试。我们开发了一种含有 ZnO 纳米颗粒 (CAZnODs) 的海藻酸钙敷料，用于治疗人类患者的糖尿病足溃疡。为了测试 CAZnOD 的功效，我们设计了一项随机对照临床实验，用于 26 名患有足部溃疡的 T2D 患者。患者被随机分为两组：G1 组用海藻酸钙和 NPs 治疗（G1；n = 16），第 2 组接受没有 NPs 的治疗（G2，n = 10）。每 48 小时更换一次绷带。方案的持续时间确定为 10 周。在这里，我们报告患者实现了愈合，在使用海藻酸钙 NPs 治疗的 G1 期伤口闭合率为 75%，而在 G2（不含 NPs 的海藻酸钙）治疗中为 71%（p = 0.011）。G1期平均愈合时间为48天，G2期为72天。我们的数据表明，CAZnODs 耐受性良好，不会干扰伤口愈合过程。最终伤口面积和愈合时间支持这样的假设，即使用含有纳米颗粒的海藻酸钙敷料可以诱导更好的组织再生，同时避免 T2D 并发症，如继发感染。在用海藻酸钙 NPs 治疗的 G1 中伤口闭合率为 75%，而在 G2（不含 NPs 的海藻酸钙）治疗中为 71%（p = 0.011）。G1期平均愈合时间为48天，G2期为72天。我们的数据表明，CAZnODs 耐受性良好，不会干扰伤口愈合过程。最终伤口面积和愈合时间支持这样的假设，即使用含有纳米颗粒的海藻酸钙敷料可以诱导更好的组织再生，同时避免 T2D 并发症，如继发感染。在用海藻酸钙 NPs 治疗的 G1 中伤口闭合率为 75%，而在 G2（不含 NPs 的海藻酸钙）治疗中为 71%（p = 0.011）。G1期平均愈合时间为48天，G2期为72天。我们的数据表明，CAZnODs 耐受性良好，不会干扰伤口愈合过程。最终伤口面积和愈合时间支持这样的假设，即使用含有纳米颗粒的海藻酸钙敷料可以诱导更好的组织再生，同时避免 T2D 并发症，如继发感染。