Chronic Dermal Ulcer Healing Enhanced with Monophasic Pulsed Electrical Stimulation

The purposes of this randomized, double-blind, multicenter study were to compare healing of chronic dermal ulcers treated with pulsed electrical stimulation with healing of similar wounds treated with sham electrical stimulation and to evaluate patient tolerance to the therapeutic protocol. Forty-seven patients, aged 29 to 91 years, with 50 stage II, III, and IV ulcers were randomly assigned to either a treatment group (n=26) or a control (sham treatment) group (n=24). Treated wounds received 30 minutes of pulsed cathodal electrical stimulation twice daily at a pulse frequency of 128 pulses per second (pps) and a peak amplitude of 29.2 mA if the wound contained necrotic tissue or any drainage that was not serosanguinous. A saline-moistened nontreatment electrode was applied 30.5 cm (12 in) cephalad from the wound. This protocol was continued for 3 days after the wound was debrided or exhibited serosanguinous drainage. Thereafter, the polarity of the treatment electrode on the wound was changed every 3 days until the wound progressed to a stage II classification. The pulse frequency was then reduced to 64 pps, and the treatment electrode polarity was changed daily until the wound was healed. Patients in the control group were treated with the same protocol, except they received sham electrical stimulation. After 4 weeks, wounds in the treatment and control groups were 44% and 67% of their initial size, respectively. The healing rates per week for the treatment and control groups were 14% and 8.25%, respectively. The results of this study indicate that pulsed electrical stimulation has a beneficial effect on healing stage II, III, and IV chronic dermal ulcers

Improved Healing of Pressure Ulcers Using Dermapulse, A New Electrical Stimulation Device

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 L x W 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 wound 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% vs. 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% vs. 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

Use of Dermagraft, a Cultured Human Dermis, to Treat Diabetic Foot Ulcers.

OBJECTIVE: To assess the effect of a tissue-engineered human dermis (Dermagraft) in healing diabetic foot ulcers. RESEARCH DESIGN AND METHODS: This controlled prospective multicenter randomized single-blinded pilot study evaluated healing over a 12-week period in 50 patients with diabetic foot ulcers. These patients were randomized into four groups (three different dosage regimens of Dermagraft and one control group). All patients received identical care except for the use of Dermagraft tissue. Ulcer healing was assessed by percentage of wounds achieving complete or 50% closure, time to complete or 50% closure, and volume and area measurements. RESULTS: Ulcers treated with the highest dosage of Dermagraft, one piece applied weekly for 8 weeks (group A), healed significantly more often than those treated with conventional wound closure methods; 50% (6 of 12) of the Dermagraft-treated and 8% (1 of 13) of the control ulcers healed completely (P = 0.03). The percentage of wounds achieving 50% closure was also significantly higher (75 vs. 23%; P = 0.018), and the time to complete or 50% closure was faster (P = 0.056). The group A regimen was more effective than other treatment regimens. All three were better than the control, however, and a dose-response was observed. There were no safety concerns. After a mean of 14 months of follow-up (range 11-22 months), there were no recurrences in the Dermagraft-healed ulcers. CONCLUSIONS: Dermagraft was associated with more complete and rapid healing in diabetic foot ulcers. The recurrence data may indicate an improved quality of wound healing