diabetic acute Charcot foot (Charcot neuroarthropathy)
Conditions
Brief summary
Time from first injection of IP until the time point where the acute Charcot foot is clinically healed/in remission, ie. the temperature difference at the site maximum temperature on the affected Charcot foot is < 2 degrees Celsius compared to the similar site on the contra-lateral foot, measured using an infrared thermometer, and edema and redness of the skin has subsided – at two subsequent visits 4 weeks apart.
Detailed description
Fraction of clinical healed participants at each study visit. Fraction of healing on X-rays and MRI (or PET/CT or Scintigram) at the time of clinical healing and at the End of trial. Number of relapses (defined as need for/prescription of off- loading with cast of the Charcot foot again) ...
Interventions
DRUG1 ml saline
DRUGsodiumchloride 9 mg/ml "Fresenius Kabi" for subcutaneous injection
Sponsors
Region Hovedstaden, Region Hovedstaden, Region Hovedstaden
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time from first injection of IP until the time point where the acute Charcot foot is clinically healed/in remission, ie. the temperature difference at the site maximum temperature on the affected Charcot foot is < 2 degrees Celsius compared to the similar site on the contra-lateral foot, measured using an infrared thermometer, and edema and redness of the skin has subsided – at two subsequent visits 4 weeks apart. | — |
Secondary
| Measure | Time frame |
|---|---|
| Fraction of clinical healed participants at each study visit. Fraction of healing on X-rays and MRI (or PET/CT or Scintigram) at the time of clinical healing and at the End of trial. Number of relapses (defined as need for/prescription of off- loading with cast of the Charcot foot again) ... | — |
Countries
Denmark
Outcome results
None listed