Efficacy of low-level laser therapy in the management of stage III decubitus ulcers: a prospective, observer-blinded multicentre randomised clinical trial.

Low-level laser therapy (LLLT) has been suggested as a promising treatment option for open wounds. In view of the absence of randomised studies with sufficiently large sample sizes, we assessed the efficacy of LLLT in the treatment of stage III decubitus ulcers. We performed a prospective, observer-blinded multicentre randomised clinical trial to assess the effect of LLLT as adjuvant to standard decubitus care. A total of 86 patients were enrolled into the study. Treatment was the prevailing consensus decubitus treatment (n=47); one group (n=39) had LLLT in addition, five times a week over a period of 6 weeks. The primary outcome measure was the absolute (mm2) and relative (%) wound size reduction at 6 weeks compared to baseline. Secondary outcome measures were the number of patients developing a stage IV ulcer during the study period, and the median change in Norton scores at 6 weeks compared to baseline. Based on the intention-to-treat principle, using last-observation-carried-forward analyses, Mann-Whitney U tests showed that the differences between the two groups in terms of absolute improvement (p=0.23) and relative improvement (p=0.42) were not significant. Because the wound size areas were non-normally distributed, we also analysed the data after logarithmic transformation of the wound size measurements. No significant difference in log(e) improvement scores between groups could be demonstrated (unpaired t-test: p=0.59). During the treatment period 11% of the patients in the control group and 8% of the patients in the LLLT group developed a stage IV decubitus ulcer (Fisher's exact test: p=0.72). The patients' Norton scores did not change during the treatment period. In this trial we found no evidence that justifies using low-level laser therapy as an adjuvant to the consensus decubitus ulcer treatment.