A prospective randomized study of 980 nm diode laser-assisted venous ulcer healing on 34 patients.

Venous ulcers are chronic wounds affecting up to 1% of adults in developed countries. Considering that noncontact normothermic therapy has been shown to modify the wound healing process, we conducted a prospective comparative clinical trial aimed at evaluating 980 nm diode laser in laser-assisted venous ulcer healing. Thirty-four Caucasian patients with venous leg ulcers were included in the study and separated into two homogenous groups based on age, sex ratio, size, and etiologies of the ulcers. In the laser group, 980 nm InGasAs diode laser (power 15 W, spot size 8 mm, time 3 seconds, fluence 90 J/cm(2) ) was applied weekly for 9 weeks to the ulcers in a homogenous standardized manner, resulting in a local temperature of 45-50 °C, which was controlled with a thermal infrared camera. Complete healing, reduction in size, and pain during and between each procedure were evaluated each time. Of the 18 patients in the laser group, three (16.7%) were completely healed during laser treatment. In the control group (16 patients), the healing was complete for four patients (25%). This difference was not significant (p=0.62). At the ninth follow-up visit, in the control group, the ulcers had decreased on an average to 94.3% of the original area of the ulcers. In the laser group, the decrease was to 74.2% of the original area of the ulcers. Again, this difference was not significant (p=0.60). The mean VAS score between each treatment was 2.7 (0.5-4.4) in the laser group compared with 3.8 (2.3-5.0) in the control group (0.13<p<0.86). During the treatment, the mean VAS score was 1.8 (0.2-3.8) in the laser group compared with 3.8 (2.1-6.0) in the control group (0.08<p<0.67). 980 nm diode laser-assisted venous ulcer healing was easy to perform and very well tolerated. However, there were no statistically significant differences in reduction of ulcer size between the two groups, suggesting that this particular laser regimen does not promote wound healing. Additional studies involving larger patient populations and an increased frequency of treatment should be performed to confirm our initial conclusions.

RCT Entities:   Population Interventions Outcomes