Charcot neuroarthropathy (CN) is a condition in diabetic patients characterized by foot swelling, redness, and a temperature difference exceeding 2˚C compared to the other foot. The study compares two treatments: a standard knee-high, non-removable total contact cast (TCC) and a non-removable knee-high walker. Both aim to immobilize and offload the foot to promote healing. The study will involve diabetic patients with specific criteria and exclude those with conditions like foot ulcers or severe kidney issues. Patients will be randomly assigned to one of the two treatments and followed for up to a year. The primary goal is to see how many patients achieve remission within six months, with secondary goals including remission within twelve months, time to remission, quality of life, and foot health. Statistical tests will be used to analyze the data and determine the effectiveness of each treatment. The study aims to improve CN treatment and provide better options for patients.
Type 2 Diabetes Mellitus
Unilateral pedal swelling
Active Charcot Neuroarthropathy
Age: 18 years and above.
presence of pedal ulcer,
osteoporosis (T score <-2.5 at lumbar spine or hip),
gout,
active peptic ulcer disease,
Factorial
Total Contact Cast
DeviceKnee High Fiber Glass Total contact Cast
Posterior Slab
DevicePosterior Slab Knee high non walking
Efficacy of posterior Slab
Proportion of participants achieving active CNO remission with Posterior slab compared to Total contact Cast
Proportion of participants achieving remission 48 weeks
Proportion of participants achieving remission within a duration of 12 months from randomization,
Time to achieve remission
Time (in weeks) to achieve remission as defined by dermal thermometry in two arms.
Life Quality 1
Foot Health Status Questionnaire Higher score means greator disability and lower score is better and outcome of interest; Score of 50 is poor and lesser than 10 is best
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