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Fibreglass Total Contact Casting, Removable Cast Walkers, and Irremovable Cast Walkers to Treat Diabetic Neuropathic Foot Ulcers: A Health Technology Assessment.

BACKGROUND
Diabetic neuropathic foot ulcers are a risk factor for lower leg amputation. Many experts recommend offloading with fibreglass total contact casting, removable cast walkers, and irremovable cast walkers as a way to treat these ulcers.


METHODS
We completed a health technology assessment, which included an evaluation of clinical benefits and harms, value for money, and patient preferences for offloading devices. We performed a systematic literature search on August 17, 2016, to identify randomized controlled trials that compared fibreglass total contact casting, removable cast walkers, and irremovable cast walkers with other treatments (offloading or non-offloading) in patients with diabetic neuropathic foot ulcers. We developed a decision-analytic model to assess the cost-effectiveness of fibreglass total contact casting, removable cast walkers, and irremovable cast walkers, and we conducted a 5-year budget impact analysis. Finally, we interviewed people with diabetes who had lived experience with foot ulcers, asking them about the different offloading devices and the factors that influenced their treatment choices.


RESULTS
We identified 13 randomized controlled trials. The evidence suggests that total contact casting, removable cast walkers, and irremovable cast walkers are beneficial in the treatment of neuropathic, noninfected foot ulcers in patients with diabetes but without severe peripheral arterial disease. Compared to removable cast walkers, ulcer healing was improved with total contact casting (moderate quality evidence; risk difference 0.17 [95% confidence interval 0.00-0.33]) and irremovable cast walkers (low quality evidence; risk difference 0.21 [95% confidence interval 0.01-0.40]). We found no difference in ulcer healing between total contact casting and irremovable cast walkers (low quality evidence; risk difference 0.02 [95% confidence interval -0.11-0.14]). The economic analysis showed that total contact casting and irremovable cast walkers were less expensive and led to more health outcome gains (e.g., ulcers healed and quality-adjusted life-years) than removable cast walkers. Irremovable cast walkers were as effective as total contact casting and were associated with lower costs. The 5-year budget impact of funding total contact casting, removable cast walkers, and irremovable cast walkers (device costs only at 100% access) would be $17 to $20 million per year. The patients we interviewed felt that wound healing was improved with total contact casting than with removable cast walkers, but that removable cast walkers were more convenient and came with a lower cost burden. They reported no experience or familiarity with irremovable cast walkers.


CONCLUSIONS
Ulcer healing improved with total contact casting, irremovable cast walkers, and removable cast walkers, but total contact casting and irremovable cast walkers had higher rates of ulcer healing than removable cast walkers. Increased access to offloading devices could result in cost savings for the health system because of fewer amputations. Patients with diabetic foot ulcers reported a preference for total contact casting over removable cast walkers, largely because they perceived wound healing to be improved with total contact casting. However, cost, comfort, and convenience are concerns for patients.