RECRUITINGINTERVENTIONAL

Contact Cast Versus Posterior Slab as Offloading Modality for Charcot Neuroarthropathy

Contact Cast Versus Posterior Slab as Offloading Modality for Charcot Neuroarthropathy of Foot in Diabetes (OFFLOAD Study): A Multicentric, Non-inferiority Study

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - Type 2 Diabetes Mellitus - Unilateral pedal swelling - Active Charcot Neuroarthropathy - Age: 18 years and above. - Ability to Provide Consent Who Should NOT Join This Trial: - presence of pedal ulcer, - osteoporosis (T score \<-2.5 at lumbar spine or hip), - gout, - active peptic ulcer disease, - steroid intake in the last three months, - estimated glomerular filtration rate (eGFR) \<30 ml/min/m2, - active dental caries or invasive dental procedure, - peripheral vascular disease (ABI \< 0.7), - bilateral foot involvement, - pregnant/ lactating women and - those who had recently received antiresorptive agents (in the previous 12 months). - Negative consent Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

Inclusion Criteria: * Type 2 Diabetes Mellitus * Unilateral pedal swelling * Active Charcot Neuroarthropathy * Age: 18 years and above. * Ability to Provide Consent Exclusion Criteria: * presence of pedal ulcer, * osteoporosis (T score \<-2.5 at lumbar spine or hip), * gout, * active peptic ulcer disease, * steroid intake in the last three months, * estimated glomerular filtration rate (eGFR) \<30 ml/min/m2, * active dental caries or invasive dental procedure, * peripheral vascular disease (ABI \< 0.7), * bilateral foot involvement, * pregnant/ lactating women and * those who had recently received antiresorptive agents (in the previous 12 months). * Negative consent

Treatments Being Tested

DEVICE

Total Contact Cast

Knee High Fiber Glass Total contact Cast

DEVICE

Posterior Slab

Posterior Slab Knee high non walking

Locations (1)

Department of Endocrinology, PGIMER

Chandigarh, India