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Contact Cast Versus Posterior Slab as Offloading Modality for Charcot Neuroarthropathy

RecruitingNAAges 18 Years - anyAllPost Graduate Institute of Medical Education and โ€ฆ
NCT06573554 on ClinicalTrials.gov โ†—
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In plain words

What the trial is, and whether it could suit you

Charcot neuroarthropathy (CN) is a condition in diabetic patients characterized by foot swelling, redness, and a temperature difference exceeding 2หšC 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

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๐Ÿ“‹ Eligibility rules (as published)
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
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What it tests

  • Total Contact Cast
  • Posterior Slab
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Where

1 site
Department of Endocrinology, PGIMER
Chandigarh, India
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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