Blue Light in the treatment of pressure ulcers

The RISE UP clinical study in brief

The clinical trial was conducted at a rehabilitation hospital in Italy with the aim to assess the effectiveness of Photobiomodulation with Blue Light (EmoLED) in promoting the healing of pressure ulcers.

To describe the state of a pressure ulcer, the EPUAP (European Pressure Ulcer Advisory Panel) and NPUAP (Pressure Ulcer Advisory Panel) recommend dividing pressure ulcers stages from 1 to 4: stage 1 – Persistent erythema; stage 2 – Partial thickness tissue loss; stage 3 – Total thickness tissue loss; stage 4 – Loss of subcutaneous tissue.

The R.I.S.E.U.P. study was designed to evaluate the effectiveness of the EmoLED medical device in patients with stage 2 and stage 3 pressure ulcers by comparing an existing standard of care (Control group) with a protocol that included the administration of the EmoLED treatment in addition to the standard of care (Treatment group). All the patients have been treated three times a week for four consecutive weeks.

Objective

The pressure ulcers healing progress was assessed by the Pressure Ulcer Scale for Healing (PUSH). The primary objective of the study was to compare the average difference in PUSH score between the first and the last visit in the two groups (Treatment vs Control). PUSH scale evaluates ulcers healing during time by considering three parameters: lesions dimensions, exudate amount and tissue type on bed wound. The total score ranges from 0 (completely healed) to 17 (the worst state of the wound).

Patients

A total of 48 eligible patients were enrolled and randomly assigned to two groups (Treatment: EmoLED medical device and Control: standard of care only). 8 patients were withdrawn from the study: five patients were dropped out for reasons other than ulcer treatment and three patients were mistakenly enrolled (non-compliant to lesions inclusion criteria). Forty patients completed the study: 20 in the Treatment group and 20 in the Control group. The total population included 33 males (69%) and 15 females (31%) with a mean age (years) of 74.4 ± 9.79 (range 50-91). 25 stage II pressure ulcers and 23 stage III pressure ulcers were treated.

Results

Considering only the patients that have completed the trial (PP analysis), after 4 weeks the mena PUSH reduction in the Control group was 2.10 (SD 3.9; median 1.5) and the mean PUSH reduction in the Treatment  group was 3.70 (SD 3.2; median 3.0). The Treatment group demonstrated a greater reduction on the PUSH scale score (+76%), although not significant (p=0.103), equivalent to an improved wound healing trend.

Since not all the 40 patients who completed the study protocol had a reduction of the PUSH scale score, the distribution of responders (patients having an improvement >0 on the PUSH scale) in the two groups was analyzed and a higher percentage of Responders in the Treatment group than in the Control group (p=0.065) was registered. Furthermore, to minimize the influence of confounding variables on the probability of belonging to Responders in the two treatment groups, a logistic regression model was constructed. This model showed that the probability of belonging to Responders is higher in the Treatment group than in the Control group (97.2% vs 56.1%) and this value is statiscally significant (p=0.018).

To better analyze the phenomenon of the time course of the PUSH scale in the 4 weeks period of observation, a latent profile analysis was carried out. This analysis identifies two trajectory classes based on treatment response, one formed by highly responding subjects (class 1) and one formed by poorly responding subjects (class 2). Subsequently the probability of belonging to one of the two trajectory classes in the presence of confounders was analyzed with a binomial logistic regression analysis. The analysis shows the statistically significant association (p = 0.036) in the probability of following type 1 trajectory (responsive) if the subject belongs to the Treatment group.

Regarding safety, there were no adverse events related to the device or the study procedure, nor unknown side effects; therefore, treatment with the EmoLED medical device proved to be safe in this patient population.

Conclusions

The R.I.S.E. U.P. study showed an overall better performance of the group of patients treated with EmoLED compared to patients treated with conventional therapy alone.

The mean reduction of the PUSH score in the patients in the Treatment group was 76% greater than in the Control group (3.7 vs 2.1) with a median of the Treatment group twice that of the control group (3 vs 1.5). Patients treated with EmoLED were significantly more likely to be in the group of subjects who experienced wound improvement, according to the PUSH scale, than patients treated only with standard therapy (97.2% vs 56.1%), over the 4-week observation period. In addition to these results,  the Treatment group was found to be associated with the trajectory class formed by highly responding subjects  thus being more likely to achieve complete healing.

The study results shows that the EmoLED medical device is effective in promoting tissue repair towards complete wound healing in pressure ulcers. These types of lesions are difficult to manage and there are few effective therapies available to healthcare professionals. Therefore, this easy-to-use therapy, which may accelerate the healing process of pressure ulcers and increase the probability of a good outcome, could make a valuable contribution to the daily management of these skin lesions.

The present study confirms the positive results registered in previous clinical observations of pressure ulcers treated with Blue Light in spinal cord injured patients (see the article) ed in elderly patients (see the paper).