Clinico-Radiological Characterisation for Remission of Acute Charcot-Neuroarthropathy of Foot.

NCT06017011 | Unknown DMC

• 1 other identifier: C- PRIME Study
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Acute Charcot Neuroarthropathy

Keywords

Charcot neuroarthropathy; F18 Fluoride PET scan; MRI of the Foot; RANKL; Osteoprotegerin

Outcome Measures

Primary Outcomes (1)

• SUVmax change in F18 Fluoride PET scan

  To assess the quantitative change in SUVmax in F18- Fluoride PET of the foot from diagnosis to 6months post clinical remission and calculate the cutoff/ Delta (change in SUVmax) in comparison to clinical remission in acute charcot neuro-arthropathy.

  From baseline till 6 months post clinical remission

Secondary Outcomes (2)

• ADC values of the MRI Foot with DWI and ADC

  From baseline to 6 months post clinical remission

• RANKL and Osteoprotegerin

  From baseline to 6 months post clinical remission

Study Arms (1)

Acute charcot neuroarthropathy or Acute on Chronic charcot neuroarthropathy

Patients diagnosed with Acute charcot neuroarthropathy or Acute on Chronic charcot neuroarthropathy will be put on Total contact cast and followed till clinical remission and then after that till 6 months post clinical remission.

Other: Total contact cast

Interventions

Total contact cast OTHER

Total contact cast will be put on the patient at the diagnosis of Acute charcot neuroarthropathy and the patient will be followed till clinical remission and after that till 6months post clinical remission. F18 Fluoride PET scan and MRI of the foot with DWI and ADC sequence to be done at baseline, Clinical remission, 3months post clinical remission and 6months post clinical remission to quantitate the process of remission.

Acute charcot neuroarthropathy or Acute on Chronic charcot neuroarthropathy

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All patients with Diabetes diagnosed with acute charcot neuroarthropathy or acute on chronic charcot neuroarthropathy.

You may qualify if:

• All patients with Diabetes,
• Diagnosed both clinically as well as radiologically to be having unilateral acute charcot neuro-arthropathy.
• Irrespective of age, glycemic status, CKD staging.

You may not qualify if:

• ) The patients who are contraindicated for MRI like metallic implants, Pace maker in situ.
• \) Active infected foot ulcers 3) Osteomyelitis 4) Patients on drugs altering bone metabolism like bisphosphonates, teriparatide, Denosumab in the past 2 months.

Sponsors & Collaborators

• Post Graduate Institute of Medical Education and Research, Chandigarh: lead

Study Sites (1)

PGIMER

Chandigarh, 160012, India

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples for the estimation of free soluble RANKL and Osteoprotegerin levels.

Study Officials

• Ashu Rastogi, MD, DM

  PGIMER, Chandigarh

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ashu Rastogi, MD,DM

CONTACT

9781001046; rastogi.ashu@pgi.ac.in

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 19, 2023
• First Posted: August 30, 2023
• Study Start: October 19, 2022
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: December 13, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)