The DENOCHARCOT Trial
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-80
SponsorOle Lander Svendsen
About this trial
The aim of the present trial is to assess the efficacy of treatment of acute Charcot foot in diabetes patients with Prolia® on clinical relevant Outcomes in a randomized, double blind, placebo-controlled trial.
Eligibility criteria
Qualifiers
Age 18-80 years
Type 1 or type 2 diabetes (diagnosed diabetes for more than 3 months)
Diagnosed with acute Charcot foot defined as a unilateral red, swollen and warm foot, with a difference of skin temperature of more than 2 °C compared with the unaffected foot and with sign of Charcot on either x-rays of the foot, MRI, bone scintigram or PET/CT.
Peripheral neuropathy: Previously diagnosed and/or biothesiometri: > 25 V or lack of sensation of 10 grams monofilament on 1. toe at the acute Charcot foot.
Disqualifiers
Duration of the acute Charcot foot for more than 3 months (at the screening visit).
Existing foot ulcer on the affected foot
Previous acute or chronic Charcot of the affected foot
Planned surgery on the acute Charcot foot
Trial design
Treatments tested in this trial
- Denosumab Injection
Treatment groups
38 Participants
are divided into 2 treatment groupsSponsors and collaborators
Ole Lander Svendsen
Lead sponsor
Bispebjerg Hospital
Sponsor institution
Source ClinicalTrials.gov