Contact Cast Versus Posterior Slab as Offloading Modality for Charcot Neuroarthropathy

NCT06573554 · tracked via the Priya Life Science India tracker

Sponsor

Post Graduate Institute of Medical Education and Research, Chandigarh

Phase

Not applicable

Started

2024-12-11

Last updated

2025-01-22

Condition(s) studied

Charcot Neuroarthropathy

Investigational drug(s) / intervention(s)

Total Contact CastPosterior Slab

Total Contact Cast: Knee High Fiber Glass Total contact Cast

Posterior Slab: Posterior Slab Knee high non walking

Study 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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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

Primary outcome measure(s)

Efficacy of posterior Slab — 26 weeks
Proportion of participants achieving active CNO remission with Posterior slab compared to Total contact Cast

Trial sites (1)

Facility	City	Region	Status
Department of Endocrinology, PGIMER	Chandigarh	India	Recruiting