Romanelli Marco, Piaggesi Alberto, Scapagnini Giovanni, Dini Valentina, Janowska Agata, Iacopi Elisabetta, Scarpa Carlotta, Fauverghe Stéphane, Bassetto Franco
Wound Healing Research Unit, Division of Dermatology, School of Medicine, University of Pisa, Italy.
Diabetic Foot Section, Department of Medicine, University of Pisa, Italy.
J Wound Care. 2018 Nov 2;27(11):744-753. doi: 10.12968/jowc.2018.27.11.744.
Fluorescence biomodulation (FB), a form of photobiomodulation (PBM) that is also known as low energy level light (LELL), has become an increasingly used clinical tool to induce wound healing in wounds that remain recalcitrant to treatment. In a real-life clinical setting, the aim of the EUREKA (EvalUation of Real-lifE use of Klox biophotonic system in chronic wound mAnagement) study was to confirm the efficacy and safety of LumiHeal, a system based on FB, in the treatment of chronic wounds such as venous leg ulcers (VLUs), diabetic foot ulcers (DFUs) and pressure ulcers (PUs). The effects of this FB system on the modulation of wound healing in chronic ulcers through FB induction were previously examined in an interim analysis of this study.
A multicenter, prospective, observational, uncontrolled trial in 12 clinical sites in Italy. The wound was cleansed with saline and a 2mm thick layer of a chromophore gel was applied to the affected area in a biweekly regimen. The area was then illuminated with the LED activator for five minutes at a distance of 5cm. Treatment was used in combination with standard of care specific to each type of chronic wound (VLU, DFU, PU). Wound area evaluation was assessed using the Silhouette Imaging System and quality of life (QoL) with the Cardiff Wound Impact Schedule (CWIS). A seven-point evaluation of the clinicans' view was also examined.
We enrolled 100 subjects, with the final analysis including 99 patients/ulcers consisting of 52 VLUs, 32 DFUs and 15 PUs. Total wound closure at the end of the study was achieved in 47 patients by aetiology: 26 VLUs (50% of VLUs); 16 DFUs (50% of DFUs); and five PUs (33.3% of PUs). The mean wound area regression at last study assessment was significant for VLUs (41.0%; p<0.001) and DFUs (52.4%; p<0.001). After four weeks of treatment, it was possible to significantly predict if the ulcer would respond (defined as a decrease of wound size) to the study treatment. Adherence was high (95.2%) and no related serious adverse events were reported during the study. QoL significantly improved, with an increase of 15.4% of the total score, using the CWIS (p<0.001).
The study confirmed a positive efficacy profile of the FB system in inducing the wound healing process in three different types of hard-to-heal chronic wounds. The treatment was shown to be safe and well tolerated by the patients, with a significant improvement in patient QoL. This approach offers an effective modality for the treatment of hard-to-heal chronic ulcers.
荧光生物调制（FB）是光生物调制（PBM）的一种形式，也被称为低能量光（LELL），它已成为一种越来越常用的临床工具，用于促进那些对治疗反应不佳的伤口愈合。在实际临床环境中，EUREKA（慢性伤口管理中Klox生物光子系统的实际应用评估）研究的目的是确认基于FB的LumiHeal系统在治疗慢性伤口（如腿部静脉溃疡（VLU）、糖尿病足溃疡（DFU）和压疮（PU））方面的疗效和安全性。此前在该研究的中期分析中，已对这种FB系统通过诱导FB对慢性溃疡伤口愈合的调节作用进行了研究。
在意大利的12个临床地点进行的一项多中心、前瞻性、观察性、非对照试验。用生理盐水清洗伤口，并每两周一次在受影响区域涂抹一层2毫米厚的发色团凝胶。然后用LED激活器在距离5厘米处照射该区域5分钟。治疗与每种慢性伤口（VLU、DFU、PU）特定的标准护理相结合。使用轮廓成像系统评估伤口面积，并使用卡迪夫伤口影响量表（CWIS）评估生活质量（QoL）。还对临床医生的观点进行了七点评估。
我们招募了100名受试者，最终分析包括99名患者/溃疡，其中有52个VLU、32个DFU和15个PU。按病因分类，在研究结束时，47名患者实现了伤口完全闭合：26个VLU（占VLU的50%）；16个DFU（占DFU的50%）；5个PU（占PU的33.3%）。在最后一次研究评估时，VLU（41.0%；p<0.001）和DFU（52.4%；p<0.001）的平均伤口面积缩小具有统计学意义。治疗四周后，可以显著预测溃疡是否会对研究治疗产生反应（定义为伤口大小减小）。依从性很高（95.2%），并且在研究期间未报告相关严重不良事件。使用CWIS评估，QoL显著改善，总分增加了15.4%（p<0.001）。
该研究证实了FB系统在促进三种不同类型难愈合慢性伤口的愈合过程中具有积极的疗效。结果表明该治疗方法安全且患者耐受性良好，患者的QoL有显著改善。这种方法为治疗难愈合慢性溃疡提供了一种有效的方式。
