Background: Lower limb ulcers not responding to standard treatments after 8 weeks are defined as chronic wounds, and they are a significant medical problem. Blue light (410-430 nm) proved to be effective in treating wounds, but there is a lack of data on chronic wounds in clinical practice. The aim of the study was to determine if blue light photobiomodulation with EmoLED (Emoled Srl, Sesto Fiorentino, Florence, Italy) medical device in addition to standard of care is more effective compared to standard of care alone in promoting re-epithelialization of chronic wounds of lower limbs in 10 weeks.
Methods: Ninety patients affected by multiple or large area ulcers were enrolled. To minimize all variabilities, each patient has been used as control of himself. Primary endpoint was the comparison of the re-epithelialization rate expressed as a percentage of the difference between the initial and final area. Secondary endpoints were: treatment safety, pain reduction, wound area reduction trend over time, healing rate.
Results: At week 10, the wounds treated with EmoLED in addition to standard care showed a smaller residual wound area compared to the wounds treated with standard of care alone: 42.1% vs. 63.4% (P=0.029). The difference is particularly evident in venous leg ulcers, 33.3% vs. 60.1% (P=0.007). 17 treated wounds and 12 controls showed complete healing at week 10. Patients showed a significant reduction in pain (P=2×10-7).
Conclusions: Blue light treatment in addition to standard of care accelerates consistently the re-epithelialization rate of chronic wounds, especially venous leg ulcers and increases the chances of total wound healing in 10 weeks.