SLR - November 2019 - Ethan J. Knowlton
Reference: David J. Johnson, MS; Barbara J. Saar, DPM; Andrew J. Shevitz, MS; Ann H. Kim, MD; Lori Hammer, RN, BSN; Daniel E. Kendrick, MD; Pamela Moorehead, MS and Vikram S. Kashwap, MD, FACS: A Total Offloading Foot Brace for Treatment of Diabetic Foot Ulcers: Results from a Halted Randomized Control Trial. Wounds: A Compendium of Clinical research and Practice: 2018, July; 30 (7):182-185.Scientific Literature Review
Reviewed By: Ethan J. Knowlton, DPM
Residency Program: St. Vincent Hospital – Worcester, MA
Podiatric Relevance: Diabetics compose a large portion of the patient population managed by podiatrists. As incidence of diabetes increases worldwide, we can expect his trend to continue. Of the complications associated with this disorder, wounds are perhaps the most prevalent. The longer a wound remains unhealed, the greater the likelihood they can progress to infections and possibly amputations. Thus, it is paramount for physicians to remain informed on new advancements in the field and provide patient-specific care. This article highlights the use of a new offloading technology known as the Toad Anti-Gravity Brace (TAG Brace). This unique device is designed to completely suspend the extremity yet allow the patient to have continued ambulation. There is potential to decrease time to healing and improve patient outcomes.
Methods: This was a multicentered, single blinded randomized control trial comparing the TAG Brace to the current standard of care of offloading therapeutic shoe. A total of 15 patients were included in the calculations; nine received the TAG Brace while the remaining six were given standard therapeutic shoes. Each was treated at clinical visits via sharp scalpel debridement and dressed with alignate or hydrogel. Digital photographs were then taken and analyzed with computer-assisted planimetry to document ulcer status at three intervals between weeks 2-5, 6-9 and 12-15 of the study.
Results: Healing was determined by analyzing the percentage of closure. At follow up intervals one and two it was shown that the experimental group had a greater percentage of wound closure compared to the control group. Statistical analysis displayed 36 percent and 50.7 percent closure for the experimental group at periods one and two respectively, while the control group group had 6.8 percent and 17.0 percent closure within the same time intervals. It should be noted that at third follow up interval (12-15 weeks) there was no evidence of significant difference in wound percentage closure between the two test groups. It was at this point the study was halted after a futility analysis was performed.
Conclusions: While the study was halted, this device warrants further research and attention. Currently total contact casts (TCC) are arguably the gold standard to offload a diabetic foot wound. However, the TAG Brace offers additional benefits when compared to TCCs. The TAG Brace may be used in patients with vascular compromise, neuropathy and minor infections; comparatively, they are contraindications for a TCC. Compliance is also an obstacle when managing wounds. This brace, being removable, can mitigate patient concerns and promote adherence to this treatment. From a cost standpoint, this is a onetime purchase that can be used over an extended period of time at multiple patient encounters. Total contact casts require multiple applications and monitoring. Overall, this shouldn’t eliminate the use of a TCCs but instead serve as an alternative for patients that would have otherwise been excluded from casting.