研究目的
To confirm the efficacy and safety of LumiHeal, a system based on fluorescence biomodulation (FB), in the treatment of chronic wounds such as venous leg ulcers (VLUs), diabetic foot ulcers (DFUs) and pressure ulcers (PUs).
研究成果
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.
研究不足
Since the purpose of this study was to confirm the efficacy of the system in a real-life setting, there was no formal sample size calculation for each group, no randomisation and no control group. There was also a limited number of inclusion and exclusion criteria, which resulted in a heterogeneity of wound characteristics, particularly in terms of wound size.
1:Experimental Design and Method Selection:
A multicenter, prospective, observational, uncontrolled trial in 12 clinical sites in Italy.
2:Sample Selection and Data Sources:
Patients >18-years old with VLUs, DFUs or PUs were enrolled.
3:List of Experimental Equipment and Materials:
LumiHeal system (KLOX Technologies Inc., Canada), chromophore gel, LED activator, Silhouette Imaging System (ARANZ Medical, New Zealand), Cardiff Wound Impact Schedule (CWIS).
4:Experimental Procedures and Operational Workflow:
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).
5:Data Analysis Methods:
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.
独家科研数据包,助您复现前沿成果,加速创新突破
获取完整内容