Eradication of Wound Biofilms by Electrical Stimulation - Antibiofilm Agents: From Diagnosis to Treatment and Prevention - page 421

5 Low-Intensity Direct Current Clinical Studies

The first in-depth electrotherapy clinical trial was performed in 1969 by Wolcott
et al. ( 1969 ), in which SWC plus LIDC was applied directly to 75 ischemic skin
ulcers over the course of a year and a half. In this nonrandom clinical trial, LIDC
treatment entailed three daily courses of LIDC, given for 2 h at an intensity range of
20

A-1 mA. The authors reported a mean healing rate of 13.4 % per week for the
electrical treated 75 ischemic skin ulcers. A major limitation of this study was that
the LIDC-treated ischemic ulcers lacked a proper control group for comparison.
However, the authors also reported that eight patients suffered from bilateral ulcers
which were similar in size and location and thus could be utilized as ideal control
for the LIDC-treated groups. From these eight patients it was observed that the
untreated control ulcers healed at a rate of 5 % per week in comparison to 27 % per
week for the LIDC-treated group. In 1985 Carley and Wainapel conducted an
unknown blind, randomized clinical trial (RCT), treating 15 inpatient wounds
with SWC and 15 with SWC + LIDC for 5 weeks (Carley and Wainapel 1985 ).
For this study LIDC was given twice daily, for 2 h at an intensity of 300-700

μ

μ

A.
Following 5 weeks of therapy the mean healing rate of the control group was 45 %
as compared to the 89 % in the LIDC-treated group. The authors also observed
wounds that opened up and became infected in the control group following the
5-week study. However, in the LIDC-treated group, the wounds closed and did not
experience infection. More recently, Adunsky et al. conducted a double-blind RCT
on 63 patients suffering from pressure ulcers with 8 weeks of treatment and
12 weeks of follow-up (Adunsky and Ohry 2005 ). Interestingly, in this study the
authors developed their own ESTHR device termed the “decubitus direct current
treatment” (DDCT), which distributed a mixture of direct and alternating current
into the wound and was able to determine wound size and record patient data and
the current of electricity in the wound before and after treatment. All patients
received SWC (debridement and colloidal dressing), while 35 patients were ran-
domly selected to receive DDCT, and 28 other patients received a placebo (sham)
treatment. The course of DCCT began with three 20-min sessions daily, but was
reduced to two daily sessions after 14 days for undeclared reasons. The electrical
parameters of DCCT were not reported. On day 45, the mean healing rate observed
in the DDCT group was 44 %, as compared to 14 % in the control group. When the
authors conducted a follow-up, they observed no significant differences in wound
closure at days 57 and 145. A clear limitation and potential counter indication for
this device are that 25 patients dropped out of the study for unstated reasons. These
studies support the use of LIDC to treat non-healing wound infections, though
further studies were done to examine what effect LIDC had on the bacterial wound
burden.