Local therapy and treatment costs of chronic, venous leg ulcers with electrical stimulation (Dermapulse): a prospective, placebo controlled, double blind trial.

The purpose of our study was the evaluation of the therapeutic benefit and the economical profit of low-frequency pulsed current applied to therapy-resistant venous leg ulcers. We investigated 39 patients in a prospective, placebo-controlled, double blind study on the effect of low-frequency pulsed current (Dermapulse) on healing in chronic venous ulcers during a 4-month course of treatment. All patients had chronic venous ulcers. The following criteria were recorded: ulcer size, pain, capillary density, and transcutaneous oxygen partial pressure. In verum group 3, ulcers healed and ulcer area was reduced significantly. In placebo group two ulcers healed. Ulcer size was reduced significantly in each group (paired test), the difference of ulcer area reduction between the "verum" and the placebo group (unpaired test) was not significant. Capillary density in the ulcer increased in both groups. In verum group, electrical stimulation led to rapid and lasting reduction of pain (unpaired test, p=0.049). By means of the process calculation method for the subgroup of outpatients this treatment method was economically effective. Electrical stimulation seems to be a viable treatment option for therapy-resistant venous leg ulcers.

RCT Entities:   Population Interventions Outcomes