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, Pisa.
Diabetic Foot Section, Department of Medicine, University of Pisa, Pisa.
Drug Des Devel Ther. 2017 Dec 11;11:3551-3558. doi: 10.2147/DDDT.S142580. eCollection 2017.
Interest has grown regarding photobiomodulation (PBM) with low-level light therapy, which has been shown to positively affect the stages of the wound healing process. In a real-life context clinical setting, the objective of the EUREKA study was to investigate efficacy, safety, and quality of life associated with the use of a BioPhotonic gel (LumiHeal™) in the treatment of chronic wounds such as venous leg ulcers (VLUs), diabetic foot ulcers (DFUs), and pressure ulcers (PUs). This BioPhotonic gel represents a new, first-in-class emission spectrum of light, including fluorescence, to induce PBM and modulate healing.
The multicenter, prospective, interventional, uncontrolled, open-label study enrolled 100 patients in 12 wound centers in Italy. We performed an early interim analysis based on the first 33 subjects (13 VLU, 17 DFU, 3 PU) in seven centers who completed the study.
Seventeen patients (52%) achieved total wound closure (full re-epithelialization for 2 weeks) during the study period. Two patients (6%) were considered "almost closed" (decrease of the wound area of more than 90% at study end) and three others (9%) were considered "ready for skin grafting". No related serious adverse events were observed, and the compliance was excellent. After the treatment, the average time to "pain-free" was 11.9 days in the VLU group. Quality of life was improved with overall increase of 26.4% of the total score (Cardiff Wound Impact Schedule, =0.001).
The study revealed a positive efficacy profile of the BioPhotonic gel in promoting wound healing and reactivating the healing process in different types of chronic, hard-to-heal wounds. The treatment was shown to be safe and well tolerated by the patients, and a reduction of pain perception was also detected during the treatment period. The improvement of the quality of life was accompanied by a high level of clinician satisfaction.
低水平光疗的光生物调节作用（PBM）已引发越来越多的关注，研究表明其对伤口愈合过程的各个阶段均有积极影响。在现实临床环境中，EUREKA研究的目的是调查使用一种生物光子凝胶（LumiHeal™）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））的疗效、安全性及生活质量。这种生物光子凝胶代表了一种新型的、同类首创的光发射光谱，包括荧光，可诱导PBM并调节愈合。
这项多中心、前瞻性、干预性、非对照、开放标签研究在意大利的12个伤口中心招募了100名患者。我们基于7个中心完成研究的前33名受试者（13例VLU、17例DFU、3例PU）进行了早期中期分析。
在研究期间，17名患者（52%）实现了伤口完全闭合（完全重新上皮化2周）。2名患者（6%）被认为“几乎闭合”（研究结束时伤口面积减少超过90%），另外3名患者（9%）被认为“准备进行皮肤移植”。未观察到相关严重不良事件，依从性良好。治疗后，VLU组达到“无痛”的平均时间为11.9天。生活质量得到改善，总分总体提高了26.4%（加的夫伤口影响量表，=0.001）。
该研究揭示了生物光子凝胶在促进不同类型慢性难愈合伤口的愈合及重新激活愈合过程方面具有积极的疗效。结果表明该治疗安全且患者耐受性良好，在治疗期间还检测到疼痛感知有所减轻。生活质量的改善伴随着临床医生的高度满意度。
