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NCT06017011
Clinico-Radiological Characterisation for Remission of Acute Charcot-Neuroarthropathy of Foot.
trial testing Total contact cast in Acute Charcot Neuroarthropathy in 25 participants. Status unknown.
31 December 2024
Quick facts
| Lead sponsor | Post Graduate Institute of Medical Education and Research, Chandigarh |
|---|---|
| Status | Status unknown |
| Study type | OBSERVATIONAL |
| Enrollment | 25 |
| Start date | 19 October 2022 |
| Primary completion | 31 December 2024 |
| Estimated completion | 31 December 2024 |
| Sites | 1 location across India |
Drugs / interventions tested
- Total contact cast
Conditions studied
- Acute Charcot Neuroarthropathy — all drugs for Acute Charcot Neuroarthropathy →
Sponsor
Post Graduate Institute of Medical Education and Research, Chandigarh
Who can join
Eligibility, any sex, with Acute Charcot Neuroarthropathy. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Charcot's neuro-arthropathy is a condition which is generally prevalent among the diabetic patients. Acute charcot's neuro-arthropathy is characterized by signs of inflammation, hot, red swelling around the involved joint along with a temperature difference of greater than 2 degree centigrade between the two feet. This is often misdiagnosed as cellulitis, sprains or deep vein thrombosis. The diagnosis of this condition is mainly made clinically and aided by x-ray of foot, MRI of foot and sometimes by bone scan. The therapy that is accepted unanimously is putting on a total contact cast. The duration of this therapy depends on the regular temperature monitoring of both the feet. When the temperature difference between the two feet comes down to less than 2 degree centigrade, then it is defined as clinical remission and the offloading of the foot is stopped. There are other modalities that have been tried for the treatment of acute charcot's neuro-arthropathy with medications like methyl prednisolone, bisphosphonates and the effects of medical management of acute charcot's neuro-arthropathy was a mixed one with no definite recommendation regarding use of medical management in this condition. If the patients are denied these treatment then there is progression of the disease process and can lead to the development of chronic changes in the form of fractures, dislocation, gangrene, foot ulcers and ultimately amputation. The end point of the treatment with total contact cast is taken as the decrease in the temperature difference of less than 2 degree centigrade between the two feet. This point is regarded as the point of clinical remission in cases of acute charcot's neuro-arthropathy. But there has been instances where there have been 12-33% of recurrences when this clinical remission has been used as a criteria for discontinuation of offloading. With time, there has been evolution in the imaging of charcot's neuro-arthropathy. There has been advent of MRI and MRS of the foot for monitoring of acute charcot's neuro-arthropathy remission which is the most sensitive technique for the recognition of early bony changes in charcot neuro-arthropathy. PET scan has also been used including bone scan and FDG PET scan, for the evaluation of acute charcot's neuro-arthropathy remission. Even with these modalities the actual remission criteria that would decrease the complication of early offloading as done at the time of clinical remission, is still missing. So here the investigators aim to monitor the process of remission of acute charcot-neuroarthropathy of foot both clinically as well as radiologically with the help of MRI of the foot with diffusion weighted and apparent diffusion coefficient imaging along with a novel PET scan for charcot's neuroarthropathy, that is F18-Fluoride PET scan which will given a quantitative estimation of the process of remission of acute charcot-neuroarthropathy in the form of SUV max. Thus this quantitative value can help to assess the trends of remission in acute charcot neuroarthropathy of foot.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
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Related trials
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06017011 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Post Graduate Institute of Medical Education and Research, Chandigarh
- Last refreshed: 13 December 2023
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