Clinico-Radiological Characterisation for Remission of Acute Charcot-Neuroarthropathy of Foot.
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ClinicalTrials.gov Identifier: NCT06017011 |
Recruitment Status :
Recruiting
First Posted : August 30, 2023
Last Update Posted : December 13, 2023
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Condition or disease | Intervention/treatment |
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Acute Charcot Neuroarthropathy | Other: Total contact cast |
Study Type : | Observational |
Estimated Enrollment : | 25 participants |
Observational Model: | Case-Only |
Time Perspective: | Prospective |
Official Title: | Clinico-Radiological Characterisation for Remission of Acute Charcot-Neuroarthropathy of Foot |
Actual Study Start Date : | October 19, 2022 |
Estimated Primary Completion Date : | December 31, 2024 |
Estimated Study Completion Date : | December 31, 2024 |
Group/Cohort | Intervention/treatment |
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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.
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Other: Total contact cast
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. |
- SUVmax change in F18 Fluoride PET scan [ Time Frame: From baseline till 6 months post clinical remission ]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.
- ADC values of the MRI Foot with DWI and ADC [ Time Frame: From baseline to 6 months post clinical remission ]To assess the trends of ADC values of the MRI Foot with DWI and ADC sequences from baseline to 6months post clinical remission in acute charcot-neuroarthropathy
- RANKL and Osteoprotegerin [ Time Frame: From baseline to 6 months post clinical remission ]To assess the role of biomarkers and imaging in monitoring the remission of acute charcot neuro-arthropathy.
Biospecimen Retention: Samples Without DNA
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Ages Eligible for Study: | Child, Adult, Older Adult |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Probability Sample |
Inclusion Criteria:
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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.
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06017011
Contact: Ashu Rastogi, MD,DM | 9781001046 | rastogi.ashu@pgi.ac.in |
India | |
PGIMER | Recruiting |
Chandigarh, India, 160012 | |
Contact: Ashu Rastogi, MD,DM 9781001046 rastogi.ashu@pgi.ac.in |
Principal Investigator: | Ashu Rastogi, MD, DM | PGIMER, Chandigarh |
Responsible Party: | Ashu Rastogi, Associate Professor, Post Graduate Institute of Medical Education and Research, Chandigarh |
ClinicalTrials.gov Identifier: | NCT06017011 |
Other Study ID Numbers: |
C- PRIME Study |
First Posted: | August 30, 2023 Key Record Dates |
Last Update Posted: | December 13, 2023 |
Last Verified: | December 2023 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Charcot neuroarthropathy F18 Fluoride PET scan MRI of the Foot RANKL Osteoprotegerin |