Department of Orthopaedic Surgery, Yonsei University College of Medicine, Seoul, South Korea.
Department of Orthopaedic Surgery, Catholic University of Daegu School of Medicine, Daegu, South Korea.
Diabetes Res Clin Pract. 2019 Oct;156:107861. doi: 10.1016/j.diabres.2019.107861. Epub 2019 Sep 16.
Because collagen is fundamental to wound healing and skin formation, collagen-containing dressing materials might be beneficial in treating diabetic foot ulcers (DFU), but supporting evidence is needed. Here, we examined the effectiveness and safety of collagen dressing material in DFU treatment.
This prospective, randomized, placebo-controlled, single-center study included patients with type 1 or 2 diabetes and palpable foot pulse who had Wagner grade 1 or 2 ulcers ≥1.0 cm with no signs of healing for ≥6 weeks. Patients were treated with foam dressing alone (control group) or with a porcine type I collagen dressing material (collagen group). Complete ulcer healing rate was the primary endpoint, and healing velocity and time to 50% size reduction were secondary endpoints.
Thirty patients were included (collagen group: 17, control group: 13). There were no significant differences in demographic factors or baseline DFU characteristics. Compared to the control group, the collagen group presented a higher rate of complete healing [82.4% vs. 38.5%, P = .022], faster healing velocity (P < .05), and shorter median time to 50% size reduction (21 versus 42 days; hazard ratio = 1.94, P < .05).
Wound management using collagen materials in DFUs showed faster and complete healing rate.
由于胶原蛋白是伤口愈合和皮肤形成的基础，因此含胶原蛋白的敷料可能有益于治疗糖尿病足溃疡（DFU），但需要有更多的证据支持。在此，我们研究了胶原蛋白敷料在 DFU 治疗中的效果和安全性。
这是一项前瞻性、随机、安慰剂对照、单中心研究，纳入了有可触及足背脉搏的 1 型或 2 型糖尿病患者，其溃疡为 Wagner 分级 1 或 2 级，且溃疡面积≥1.0cm，且无愈合迹象≥6 周。患者接受泡沫敷料（对照组）或猪 I 型胶原蛋白敷料（胶原蛋白组）单独治疗。完全溃疡愈合率是主要终点，愈合速度和达到 50%面积减少的时间是次要终点。
共纳入 30 例患者（胶原蛋白组 17 例，对照组 13 例）。两组患者的人口统计学因素或基线 DFU 特征无显著差异。与对照组相比，胶原蛋白组的完全愈合率更高[82.4%比 38.5%，P=0.022]，愈合速度更快（P<0.05），达到 50%面积减少的时间更短（21 天比 42 天；风险比=1.94，P<0.05）。
在 DFU 中使用胶原蛋白材料进行伤口管理可实现更快和更高的完全愈合率。
