Decubitus direct current treatment (DDCT) of pressure ulcers: results of a randomized double-blinded placebo controlled study.

摘要

Electrostimulation for the treatment of pressure sores remains problematic and controversial. We studied the decubitus direct current treatment (DDCT) electrostimulation treatment of pressure sores stage 3 degree, with respect to rates of ulcer closure and wound area reduction. This was a multicenter, double-blind, randomized, placebo-controlled study involving 11 departments of geriatric and rehabilitation medicine including 63 patients. We compared a placebo treated group (PG) with an active treatment group (TG). Treatment lasted for 8 consecutive weeks, followed by a 12-week-period of follow-up. At day 57 (end of treatment) and at day 147 (end of follow-up), there was no difference between the groups with regards to rates of complete closure of ulcers (p=0.28 and 0.39, respectively), as well as for the mean time needed to achieve complete wound closure (p=0.16). Absolute ulcer area reduction and speed rate of wound area reduction (reflected by change from baseline ulcer area, percentage) were betterin participants allocated in the treatment group only until day 45 (standardized estimate for trend of healing speed -0.44 and -0.14 for TG and PG, respectively). Afterwards, there were no differences between the two groups. A logistic regression analysis favored complete healing in TG, compared with PG (odds ratio 1.6, CI 0.4-4.73). Analysis of per protocol patients revealed that time needed for wound closure was 52% longer in PG (p=0.03, compared with TG). The results suggest that DDCT treatment for pressure ulcers grade 3 degree, in addition to the conservative wound care, may be useful in accelerating the healing process during the first period of care.