Stepease™ diabetic socks: An answer to efficacious indoor foot pressure relief- A prospective study

Diabetic foot ulcer is commonly seen in people with diabetes mellitus. Inadequate plantar pressure offloading has been identified as a contributing factor to development of diabetic foot ulcers. Various pressure off-loading footwear are widely available in the market but poor compliance has been reported especially for indoor usage. StepEase™ diabetic socks have been designed using Ethylene Vinyl Acetate (EVA) microspheres for better redistribution of plantar pressure. The objective of this study was to determine the efficacy of StepEase™ in redistributing the foot plantar pressure and to assess patients' satisfaction on the usage of the socks.

This was a prospective non randomized clinical trial conducted on 31 patients with diabetes mellitus with high risk foot (King's classification stage II) over a 12 weeks period. Dynamic foot plantar pressure reading was recorded at day 0, 6 weeks and 12 weeks intervals, both barefoot and with StepEase™, using Novel Pedar-X system (Novel GmbH, Munich, Germany). Patients' satisfaction and usage practice were assessed by a questionnaire.

The mean age of subjects was 57.9 years with mean body mass index (BMI) of 26 kg/m². The mean duration of diagnosis with diabetes mellitus was 10.2 years. The mean peak plantar pressure was found to be highest at the right forefoot and left heel region, 267.6 kPa (SD113.5 kPa) and 266.3 kPa (SD 94.6 kPa) respectively. There was a statistically significant reduction of mean peak pressure (P < 0.0001 to P = 0.024) in all masked regions except the left toe region ranging from 22.3 to 47.5% (53.2-117.4 kPa). The highest reduction was seen in the right toe region (47.5%). The reduction of peak pressure was still significant (P < 0.0001 to P = 0.034) at 6 weeks ranging from 24.7% to 46.8% (46.1-100.6 kPa) and at 12 weeks, which was 22.2-49.2% (40.6-91.9 kPa). Mean usage of the socks was 4.39 days per week (SD 1.82), with the mode of 4-6 h per day. Most of the subjects were satisfied or very satisfied with the StepEase™ socks (77.4%) while 87.1% agreed to continue using the socks. None had any new ulcer development or fall during the study period.

StepEase™ was significantly effective as an indoor foot pressure relieving footwear. It resulted in significant peak plantar pressure reduction by up to 49.2% and the effect was maintained for at least 12 weeks duration.