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NCT06573554

Contact Cast Versus Posterior Slab as Offloading Modality for Charcot Neuroarthropathy

Recruiting now NA Last updated 22 January 2025
What this trial tests

NA trial testing Total Contact Cast in Charcot Neuroarthropathy in 80 participants. Currently enrolling.

Timeline
11 December 2024
Primary endpoint
30 October 2026
31 March 2027

Quick facts

Lead sponsorPost Graduate Institute of Medical Education and Research, Chandigarh
PhaseNA
StatusRecruiting now
Study typeINTERVENTIONAL
Allocationrandomized
Designfactorial
Maskingdouble
Primary purposetreatment
Enrollment80
Start date11 December 2024
Primary completion30 October 2026
Estimated completion31 March 2027
Sites1 location across India

Drugs / interventions tested

Conditions studied

Sponsor

Post Graduate Institute of Medical Education and Research, Chandigarh

Who can join

18 and older, any sex, with Charcot Neuroarthropathy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Data sources for this page

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