Innovation in preventing the heel pressure injury: Design and manufacture of a heel support orthosis

Heel pressure injuries are common among patients with lower limb fractures or those on complete bed rest (CBR). Despite the availability of multiple devices, no gold standard has been established for effectively preventing these injuries. This study aimed to describe the design and development of a heel support orthosis and to assess its preliminary safety and effectiveness. After reviewing the literature and consulting experts, an initial orthosis design was created and tested for efficacy and patient safety. A prototype was made, and after approval, tested on two patients with lower limb fractures for up to three days. Following improvements, a second model was tested on five additional patients over the same period. The orthosis was evaluated for heel and shank pressure injuries, pain, burning, itching, and comfort. The orthosis supported the heel without direct surface contact, allowing for reduced pressure and improved perfusion. The device's hypoallergenic cotton fabric was soft, non-abrasive, and non-elastic. None of the patients developed pressure injuries, pain, or discomfort, and all were satisfied. Based on the pilot study findings, the heel support orthosis demonstrates potential as a valuable tool for preventing heel pressure injuries in a clinical setting.