The Effect of Low Level Laser Therapy (LLLT) on Stage III Decubitus Ulcers (Pressure Sores); a Prospective Randomised Single Blind, Multicentre Pilot Study

. This study had four main objectives (a) multicentre trial feasibility in nursing homes; (b) the applicability of registration methods; (c) the extent of wound size reduction and (d) the LLLT effect(s) on pressure sores stage III. The study was designed as a prospective randomised, single blind, multicentre clinical trial in four nursing homes, using the same prospective protocol. A total of 20 patients were enrolled into the study: 16 patients were randomised, and four patients were excluded. Treatment was the prevailing consensus decubitus treatment (n=8); one group (n=8) had 904 nm LLLT in addition, five times a week over a period of 6 weeks. The main outcome measure was the median wound size at six weeks after intervention. No statistical significant difference in wound size was found between the two groups (Mann Whitney U test; p=0.47). The sores in the LLLT group healed to a median of 83%, wounds in the control group to a median of 95% of their initial size. There was significant wound decrease within treatment arms (Friedman two-way analysis, p<0.001). It was concluded that (a) a multicentre study is feasible in nursing homes; (b) the evaluation methods are accurate, adequate and reproducible; (c) there was significant sore area reduction within groups, but there were no significant differences between treatments; and (d) the efficacy of LLLT in healing of full thickness pressure sores stage III was not demonstrated and is still a matter of debate. Paper received 7 July 1999; accepted after revision 8 October 1999.