Characterizing Acute Charcot Neuroarthropathy in Diabetic Patients
Clinico-Radiological Characterisation for Remission of Acute Charcot-Neuroarthropathy of Foot
PGIMER · NCT06017011
This study looks at how to better understand and treat foot swelling in people with diabetes who have acute Charcot neuroarthropathy by using special scans and monitoring temperature differences.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 25 (estimated) |
| Sex | All |
| Sponsor | PGIMER (unknown) |
| Drugs / interventions | Denosumab |
| Locations | 1 site (Chandigarh) |
| Trial ID | NCT06017011 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on patients with acute Charcot neuroarthropathy, a condition commonly seen in diabetics that leads to inflammation and swelling in the foot. The study aims to characterize the condition using clinical assessments and imaging techniques such as MRI and F18 Fluoride PET scans. The primary treatment involves the application of a total contact cast, with the duration of treatment determined by monitoring temperature differences between the feet. The goal is to achieve clinical remission, defined as a temperature difference of less than 2 degrees centigrade.
Who should consider this trial
Good fit: Ideal candidates for this study are diabetic patients diagnosed with unilateral acute Charcot neuroarthropathy.
Not a fit: Patients with contraindications for MRI, active infected foot ulcers, or those on certain medications affecting bone metabolism may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve the diagnosis and management of acute Charcot neuroarthropathy, potentially preventing severe complications like joint dislocation or amputation.
How similar studies have performed: While there have been studies on Charcot neuroarthropathy, this specific approach focusing on clinico-radiological characterization is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * All patients with Diabetes, 1. Diagnosed both clinically as well as radiologically to be having unilateral acute charcot neuro-arthropathy. 2. Irrespective of age, glycemic status, CKD staging. Exclusion Criteria: -1) The patients who are contraindicated for MRI like metallic implants, Pace maker in situ. 2) Active infected foot ulcers 3) Osteomyelitis 4) Patients on drugs altering bone metabolism like bisphosphonates, teriparatide, Denosumab in the past 2 months.
Where this trial is running
Chandigarh
- PGIMER — Chandigarh, India (RECRUITING)
Study contacts
- Principal investigator: Ashu Rastogi, MD, DM — PGIMER, Chandigarh
- Study coordinator: Ashu Rastogi, MD,DM
- Email: rastogi.ashu@pgi.ac.in
- Phone: 9781001046
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Acute Charcot Neuroarthropathy, Charcot neuroarthropathy, F18 Fluoride PET scan, MRI of the Foot, RANKL, Osteoprotegerin