Randomized clinical trial of the efficacy of the EmoLED medical device in the treatment of stage 2 and stage 3 pressure ulcers: the RISE_UP study

Pressure ulcers are an important public health issue, impacting quality of life and causing health deterioration. Blue light photobiomodulation has been shown promoting wound healing in vascular, diabetic, rheumatologic ulcers and lesions in spinal cord injury patients. Based on these preliminary results, this study was developed to assess the effectiveness of blue light therapy in second and third stage pressure ulcers. This study was a randomized controlled trial enrolling hospitalized patients with poor mobility. The intervention group included blue light treatment in addition to standard care, three times a week, for 4 consecutive weeks. The primary objective is the difference in the healing process by measuring the average difference of the lesion's PUSH score between the first and the last visit. The analysis shows that the mean PUSH reduction and the probability of belonging to responder patients were higher in the treatment group. A latent profile analysis that identifies two trajectory classes based on treatment response, shows an association in the probability of following best trajectory for the treatment group (30 % vs 2 %). The result shows that blue light photobiomodulation promotes recovery of tissue repair in pressure ulcers, and in stabilizing wounds that would otherwise worsen despite standard of care treatment. This therapy may be a valuable contribution to the daily management of pressure lesions since it has an excellent safety profile and the addition of this therapy to a treatment program may speed healing, improving the quality of life. (Clinicaltrials.gov Ref. numb.: NCT05130814).