A pilot randomised control trial to measure the effectiveness of combined modulated ultrasound and electric current stimulation in treating diabetic foot ulcers

Background

Diabetic foot ulcers (DFUs) are a growing medical problem worldwide reaching concerning levels (IDF, 2017). Advanced wound care therapies are continuing to evolve to match the growing epidemic. The effect of combined ultrasound and electric current stimulation (CUSECS) on DFUs is still only a new focus. This study aims to investigate if CUSECS is an effective adjunctive treatment for chronic DFU when compared with standard wound care (SWC).

Method: A randomised controlled pilot study design was employed. Eleven participants with chronic DFUs from two centres were sequentially randomised. For eight weeks the experimental group (n=6) received CUSECS and SWC treatment twice a week; the control group (n=5) received SWC treatment once a week. The CUSECS device utilised delivers ultrasound at modulating frequency (1.0-3.0 MHz) and intensity (0.0- 2.0 W/cm2) via a probe and electrostimulation at varying intensity (4000Hz–4250Hz) via electrodes. Wound size percentage was documented via photograph and measured for size. Ankle dorsiflexion, self-efficacy, economic cost, quality of life (QOL), pain and reoccurrence rates were analysed as secondary objectives.

Results / Discussion: The experimental group achieved higher rate of mean wound healing than the control group with two completing full healing in the experimental group and one completing full healing in the control group. There were no statistically significant findings. There were no direct adverse reactions to this therapy. Mental health scores to improved and physical health scores decreased in wounds which portrayed an increase in healing rates. There was no significant change in ankle dorsiflexion, self-efficacy scores or pain in either group. In the four-week follow-up, the experimental group continued to have a greater wound size improvement compared to the control group. The experimental group’s direct costings were higher however healing rate was quicker which could be extrapolated to cost reductions over time. 12

Conclusion: Results suggest that CUSECS is a useful adjunctive therapy for treatment of chronic DFUs. Further large-scale studies are needed to ascertain the effectiveness of CUSECS. The findings here indicate that CUSECS offer promise as a treatment.