Efficacy of Treatment With DENOsumab of an Acute CHARCOT Foot in Patients With Diabetes. A Multicenter, Double-blind, Randomized, Placebo-controlled Trial.
Status: Recruiting
Location: See all (8) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:
• 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.
Locations
Other Locations
Denmark
Steno Diabetes Center North
RECRUITING
Aalborg
Steno Diabetes Center Aarhus
RECRUITING
Aarhus
Bispebjerg Hospital
RECRUITING
Copenhagen Nv
Steno Diabetes Center Copenhagen
RECRUITING
Gentofte Municipality
Nordsjællands Hospital
RECRUITING
Hillerød
Hvidovre hospital
RECRUITING
Hvidovre
Zealand University Hospital
RECRUITING
Køge
Steno Diabetes Center Odense
RECRUITING
Odense
Contact Information
Primary
Ole Lander Svendsen, MD
Ole.Lander.Svendsen@regionh.dk
+4521490547
Backup
Michael Zaucha Sørensen, MD
mzs@dadlnet.dk
+4526836584
Time Frame
Start Date: 2020-11-01
Estimated Completion Date: 2026-10-01
Participants
Target number of participants: 38
Treatments
Experimental: Denosumab treated group
Participants will receive a 60 mg subcutaneous injection of Prolia upon randomization and on week 28 after the first injection provided remission of the Charcot foot has not been achieved by then
Placebo_comparator: Placebo treated group
Participants will receive an injection of placebo (saline) instead of Prolia
Related Therapeutic Areas
Sponsors
Leads: Ole Lander Svendsen