Actively Recruiting
The DENOCHARCOT Trial
Led by Ole Lander Svendsen · Updated on 2024-08-07
38
Participants Needed
8
Research Sites
308 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
The DENOCHARCOT Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 80 years
- Diagnosed type 1 or type 2 diabetes for more than 3 months
- Diagnosed with acute Charcot foot showing a unilateral red, swollen, and warm foot with skin temperature difference greater than 2 °C compared to the unaffected foot
- Evidence of Charcot foot on x-rays, MRI, bone scintigram, or PET/CT
- Peripheral neuropathy diagnosed previously or biothesiometry over 25 V or lack of sensation with 10 grams monofilament on the affected toe
You will not qualify if you...
- Duration of acute Charcot foot more than 3 months at screening
- Existing foot ulcer on the affected foot
- Previous acute or chronic Charcot of the affected foot
- Planned surgery on the affected foot
- Infection such as cellulitis or osteomyelitis in the affected foot
- Previous midfoot or proximal amputation of the affected foot
- Hypocalcemia (Serum Calcium <2.1 mmol/L or Calcium ion <1.12 mmol/L)
- Vitamin D deficiency (Serum 25-hydroxyvitamin D < 50 nmol/L)
- Renal failure (serum creatinine >200 mmol/L or eGFR <30 ml/min)
- Denosumab treatment within last 12 months
- Known hypersensitivity to Denosumab
- History of osteonecrosis of the jaw
- Poor oral hygiene or recent dental surgery within 3 months
- Planned mandibular surgery or dental implants within next 12 months
- Prior non-traumatic vertebral fracture
- Treatment with bone-affecting medication within last 12 months
- Active or chronic liver disease
- History of inflammatory arthropathies
- Medical conditions precluding safe participation
- Current treatment with cytotoxic drugs or systemic glucocorticoids
- Alcohol or drug abuse or conditions affecting study adherence
- Pregnancy, breastfeeding, or inadequate contraception
- Likely inability to comply with study visits
- Use of investigational product within last month
- Use of interfering drugs or conditions per investigator
- Cancer or clinically significant diseases interfering with trial results
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 8 locations
1
Steno Diabetes Center North
Aalborg, Denmark
Actively Recruiting
2
Steno Diabetes Center Aarhus
Aarhus, Denmark
Actively Recruiting
3
Bispebjerg Hospital
Copenhagen NV, Denmark, 2400
Actively Recruiting
4
Steno Diabetes Center Copenhagen
Gentofte Municipality, Denmark
Actively Recruiting
5
Nordsjællands Hospital
Hillerød, Denmark
Actively Recruiting
6
Hvidovre hospital
Hvidovre, Denmark
Actively Recruiting
7
Zealand University Hospital
Køge, Denmark
Actively Recruiting
8
Steno Diabetes Center Odense
Odense, Denmark
Actively Recruiting
Research Team
O
Ole Lander Svendsen, MD
CONTACT
M
Michael Zaucha Sørensen, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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