Actively Recruiting
Contact Cast Versus Posterior Slab as Offloading Modality for Charcot Neuroarthropathy
Led by Post Graduate Institute of Medical Education and Research, Chandigarh · Updated on 2025-01-22
80
Participants Needed
1
Research Sites
120 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Contact Cast Versus Posterior Slab as Offloading Modality for Charcot Neuroarthropathy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Type 2 Diabetes Mellitus
- Unilateral pedal swelling
- Active Charcot Neuroarthropathy
- Age 18 years and above
- Ability to provide consent
You will not qualify if you...
- Presence of pedal ulcer
- Osteoporosis with T score less than -2.5 at lumbar spine or hip
- Gout
- Active peptic ulcer disease
- Steroid intake in the last three months
- Estimated glomerular filtration rate (eGFR) less than 30 ml/min/m2
- Active dental caries or recent invasive dental procedure
- Peripheral vascular disease with ankle-brachial index less than 0.7
- Bilateral foot involvement
- Pregnant or lactating women
- Recent use of antiresorptive agents within the previous 12 months
- Negative consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Department of Endocrinology, PGIMER
Chandigarh, India, 160012
Actively Recruiting
Research Team
A
Ashu Rastogi, DM MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
FACTORIAL
Primary Purpose
TREATMENT
Number of Arms
2
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