Biomechanical Assessment of TCC-EZ® Kits for Diabetic Foot Ulcers

Purpose: Diabetic foot ulceration has been tied to elevated plantar pressures and the presence of neuropathy. Traditional Total-Contact Casting (tTCC) is considered the gold standard for treating diabetic foot ulcers (DFUs). However, this intervention is not applicable to some patients with active ulcers. The tTCC application also requires expertise which may not be available in all healthcare facilities, a limiting factor in its widespread implementation. Many physicians prefer the alternative route in treating DFUs which entails the use of off-the-shelf off-loading devices, such as diabetic boots. While diabetic boots are subject to patient compliance issues, they also have advantages such as being practical to implement. There are also new products such as TCC-EZ® kits on the market that offer a user-friendly casting process for healthcare providers. To the best of our knowledge, comparison of the offloading characteristics of TCC-EZ and tTCC has not been done. The purpose of this study was to determine whether plantar pressures, gait speeds, and cast weights are different between the two modalities (TCC-EZ vs. tTCC). Methods: In this ongoing pilot study, 14 individuals (nine male, five female; median age of 47.8 (40.5 to 66.1)) participated, ten were healthy and four have diabetic neuropathy. Participants were casted and instructed to complete three 30-meter 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) pedobarographic insoles. Paired t-tests were used to compare peak pressures, gait speed, and cast weights across the two modalities. All study procedures were approved by the North Texas Regional Institutional Review Board (IRB) prior to recruitment and testing, and informed consent was obtained from subjects prior to testing. 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 noticeable pressure reduction to patients with DFUs. Based on our results, faster walking speeds indicate that the product may improve patients’ ability to walk 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 modalities.