A double-blind, clinical study of pulsed electrical stimulation using the Dermapulse device was carried out on 40 pressure ulcers, randomized to receive either active (stim) or sham treatment. Electrodes were placed over saline-moistened gauze on the ulcers. An electrical current of 35mA was delivered to the wound tissues at a frequency of 128 pulses per second. Polarity was negative until the wound debrided, then alternated from positive to negative every three days. Ulcers were treated for 30 minutes twice daily for four weeks, after which sham patients could cross over to active treatment, and stim patients could continue active treatment. Ulcer healing was determined by measuring the length and width of the ulcer and calculating the LxW product. The same clinicians measured the ulcers each week, were kept blinded to treatment group, and were not the same persons who applied the treatment. Nine centers treated 40 ulcers (19 sham and 21 stim). Analysis of the characteristics of the patients, the ulcers, and concomitant would care by both univariate and multivariate analyses showed comparability of the groups. After four weeks, the stim ulcers healed more than twice as much as the sham ulcers (49.8% versus 23.4%; (p = 0.042). The stim ulcers healed 12.5% per week compared to 5.8% for the sham group. In the 15 crossover patients, four weeks of active stimulation caused nearly four times as much healing as their four weeks of sham treatment (47.9% versus 13.4%; p = 0.012). By the last week of active stimulation they had healed an average of 64%, and complete healing occurred in 40% of these ulcers after an average of nine weeks. Seventeen of the active treatment ulcers had extended therapy, and by their last week of treatment had healed an average of 75%, Forty-one percent of these ulcers healed completely after an average of 11.8 weeks. There were no significant safety problems identified.

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