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Contact Cast Versus Posterior Slab as Offloading Modality for Charcot Neuroarthropathy
Sponsor: Post Graduate Institute of Medical Education and Research, Chandigarh
Summary
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.
Official title: Contact Cast Versus Posterior Slab as Offloading Modality for Charcot Neuroarthropathy of Foot in Diabetes (OFFLOAD Study): A Multicentric, Non-inferiority Study
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
80
Start Date
2024-12-11
Completion Date
2027-03-31
Last Updated
2025-01-22
Healthy Volunteers
No
Conditions
Interventions
Total Contact Cast
Knee High Fiber Glass Total contact Cast
Posterior Slab
Posterior Slab Knee high non walking
Locations (1)
Department of Endocrinology, PGIMER
Chandigarh, India