Offloading Devices for Diabetic Foot Ulcers

Health Technology Assessment Committee Recommendations

1. Offloading devices for people with diabetic foot ulcers be publicly provided.
2. Although maximum patient and system benefits will be realized within a coordinated, equitable system of diabetes care to ensure all people who could benefit from offloading devices are reached, there will still be significant benefit from limited implementation.
3. Such an equitable system of care would be supported by an analysis of the pathway that patients with diabetes follow, from prevention through diagnosis, treatment, and care.

Health Technology Assessment Committee Findings

1. A meta-analysis was conducted on the number of ulcers healed at three months follow-up and mean time to ulcer healing. There was no statistically significant difference in the risk ratio of ulcer healing of total contact casts (TCC)compared to irremovable cast walkers (ICW), or TCC versus removable cast walkers (RCW). However, at three months, ICW was 1.4 times more likely to result in ulcer healing than RCW. For mean time to healing, there was no statistically significant difference between the three offloading devices.
2. A cost-effectiveness analysis suggests there are cost savings associated with the public provision of offloading devices. Both TCC and ICW offer increased benefit and decreased costs for the treatment of uninfected DFU. ICW was found to have the highest cost savings when compared to no offloading treatment. Compared to ICW, TCC was slightly more effective and more expansive when compared to no offloading treatments. RCW was less effective and more expensive than ICW.
3. BC health professionals interviewed perceived TCC to be the most effective for healing DFU since it cannot be removed without being cut off. TCC was also described as being expensive and associated with considerable time commitments for the patient and provider, requiring weekly cast changes and an application time of two hours. Many care providers expressed the desire to be able to use TCC but an inability to use them due to resource constraints. The air boot was the most commonly discussed and used RCW. However, it was reported to be perceived by patients as uncomfortable and causing balance issues, leading patients to not wear them. Orthotics and therapeutic shoes were perceived as appropriate, if fitted properly, for preventing DFU and for maintenance once the DFU healed.
4. Patients described months of daily wound dressing changes and long-term antibiotic treatment for infection until they heard about or sought out a specialist who fit them with an offloading device. Aside from struggling to receive timely and effective care, patients broadly described experiencing difficulties associated with following care advice from care providers who were not well-informed about offloading devices. Patients reported trying several offloading devices within their treatment course including orthotics, therapeutic shoes with inserts, air boots, and TCC. Most patients were generally satisfied with the offloading device they received and felt that it was a worthwhile investment. Patients who had received TCC reported their foot ulcer healing very quickly and reported it to be the most effective offloading device in their experience. In general, offloading devices were reported to impact patients’ mobility, sleep, and ability to shower. Additionally, several patients described experiencing stigma due to both offloading devices and amputations.
5. Budget impact analysis indicates the public provision of offloading devices would result in significant cost savings to the system, with the amount of savings varying depending on the mechanism chosen.