Biomechanical Assessment of a New Off-Loading Device for Diabetic Foot Ulcers

Background: The traditional Total Contact Cast (tTCC) has been used as the gold standard for treating diabetic foot ulcers (DFU). The application of tTCC is time consuming and requires skills, training and expertise. Recently, new products have been introduced, which offer a user-friendly casting process. One such device is the TCC-EZ®. To the best of our knowledge, comparison of the offloading characteristics of TCC-EZ and tTCC has not been done.

Purpose: The objective of this study was to determine whether plantar pressures and gait speeds vary between two modalities. 

Methods: Fourteen individuals (nine male, five female; median age of 47.8 (40.5 to 66.1)), participated in this pilot study, ten were healthy, four had diabetic neuropathy. Participants were instructed to complete three 30-m walking trials at a comfortable pace with two modalities on the day of testing in a randomized order. Time to traverse the path was captured using automated photogate sensors (Dashr Systems, Lincoln, NE), and plantar pressures were measured using Pedar (Novel, Munich, Germany) pedoparographic insoles. Paired t-tests were used to compare peak pressures, gait speed, and cast weights across the two modalities.

Results: Gait speed was significantly higher (0.96±0.20m/s vs. 0.85±0.26m/s; p=0.014) whereas cast weight (1.79 ± 0.17 kg vs. 2.09 ± 0.25 kg; p=0.001) was significantly lower in the TCC-EZ group. No difference was detected (p=0.935) in peak pressures (296±84kPa vs. 295±84kPa) between the two modalities.

Conclusion: The prefabricated kit of the TCC-EZ and its ease of application has the potential to reach a wider patient population, while offering “gold standard” pressure reduction to more patients with DFUs. Based on our results, faster walking speeds indicate that the product may be more functional to patients who prefer a more active lifestyle. Further work is needed to evaluate the activity, durability, rate of DFU healing and adverse events associated with these two approaches.