acute Charcot foot (Charcot arthropathy
Conditions
Interventions
Trade Name: Prolia
Pharmaceutical Form: Solution for injection in pre-filled syringe
Pharmaceutical form of the placebo: Solution for injection in pre-filled syringe
Route of administration of the pl
Sponsors
Ole Lander Svendsen
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • 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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 28 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10
Exclusion criteria
Exclusion criteria: • 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 • Infection (cellulitis or osteomyelitis) of the affected foot (clinically and/or radiologically proven) • Previous midfoot or proximal to mid foot amputation of the affected foot • Hypocalcemia (Serum Calcium 200 mmol/L or eGFR 1.5 (in the absence of the use of Warfarin) and AST and ALT > 2 x ULN • History of inflammatory arthropathies (rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, autoimmune arthropathy) • Pre-existing medical condition judged to preclude safe participation in the study • Current treatment with cytotoxic drugs or with systemically administered glucocorticoids • Abuse of alcohol or drugs, or presence of any condition that in the Investigators opinion may lead to poor adherence to study protocol • Pregnancy, breast feeding or planning pregnancy or not using adequate contraceptive methods. The following contraceptive products are considered to be safe: Intrauterine devices or hormonal contraception (oral contraceptive pills, implants, transdermal patches, vaginal rings or long-acting injections). • . • Likely inability to comply with the visits because of planned activity • Use of any investigational product with the last month. • Use of any drug or any other reason which in the Investigator’s opinion could interfere with the outcome of the treatment of the acute Charcot foot. • Cancer, or any clinically significant disease or disorder, except for conditions associated to the diabetes, which in the Investigator’s opinion could interfere with the results of the trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The aim of 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. The main objective is to assess the difference between Prolia and placebo in 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 Objective: The secondary objectives are to assess the difference between Prolia and placebo in: Fraction of clinical healed participants at each study visit. Fraction of healing on X-rays and MRI (or PET/CT or bone 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) Time without relapse (the time from clinical healing/remission to the relapse or to End of Trial at 12 months). Number of patients with development of complications to the acute Charcot foot, as well as number of development of foot ulcer, deformity, need for special footwear or surgery and fractures of bones in the foot, respectively. Changes in Bone mineral density (lumbar spine, and hip) by DXA, Markers of bone turnover (CTX and P1NP) and Markers of glycemic control (HbA1c) Incidence of Adverse Events and Serious Adverse Events ;Primary end point(s): 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 thermo | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 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) Time without relapse (the time from clinical healing/remission to the relapse or to End of Trial at 12 months). Number of patients with development of complications to the acute Charcot foot, as well as number of development of foot ulcer, deformity, need for special footwear or surgery and fractures of bones in the foot, respectively. Changes in Bone Mineral Density (lumbar spine,and hip) by DXA, markers of bone turnover (CTX and P1NP) and markers of glycemic control (HbA1c) Incidence of Adverse Events and Serious Adverse Events ;Timepoint(s) of evaluation of this end point: Each study visit for some of the endpoints, and at baseline, at clinical healing, and at end of trial (12 months after first IP injection) for other endpoints | — |
Countries
Denmark, United States
Contacts
Public ContactSponsor and Principal Investigator
Ole Lander Svendsen
Outcome results
None listed