What this Trial Is About

Charcot neuroarthropathy (CN) is a foot condition affecting diabetic patients, marked by swelling, redness, and a temperature difference greater than 2°C compared to the other foot. This research compares two treatments designed to immobilize and relieve pressure on the foot to promote healing: a knee-high, non-removable total contact cast (TCC) and a non-removable knee-high walker called a posterior slab. The study aims to find out which treatment is more effective in managing active CN, a condition influenced by inflammatory processes and bone changes in the foot, with no prior head-to-head comparison of these devices. Participants with active CN will be randomly assigned to either the TCC group or the posterior slab group. Both devices will be applied as non-removable, knee-high supports to immobilize the foot. Patients will have their casts changed every two weeks to adjust for swelling reduction, and temperature measurements of the foot will be taken at each visit. Blood tests and inflammatory markers will be collected at the start and at remission or after 12 months. The study will follow patients for up to one year to monitor healing and remission progress. Throughout the study, participants will have regular clinical visits every two weeks, including foot temperature checks and cast adjustments. Researchers will use imaging like X-rays or MRI to confirm diagnosis and monitor the foot. Outcome measures include the rate of remission within six months, time to remission, quality of life, and foot health. Safety and effectiveness will be assessed using statistical analyses, and the study plans to enroll 80 patients to compare the two treatments' outcomes.

Contact Cast Versus Posterior Slab as Offloading Modality for Charcot Neuroarthropathy