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RECRUITING
NCT06573554
NA

Contact Cast Versus Posterior Slab as Offloading Modality for Charcot Neuroarthropathy

Sponsor: Post Graduate Institute of Medical Education and Research, Chandigarh

View on ClinicalTrials.gov

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

Interventions

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