A Phase 3 interventional study of Denosumab Injection in Charcot Foot and Diabetes Mellitus, sponsored by Ole Lander Svendsen. Recruiting at 8 sites in Denmark. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-08-07.
Sponsored by Ole Lander Svendsen · Phase 3, Interventional, and Treatment
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.
After giving informed consent and being enrolled, patients will be randomized to one of two group given either Denosumab treatment or injection with placebo. The patients will then undergo a 52 week follow up with regular controls to asses if clinical signs of Charcot is in remission, which will be verified using relevant radiological modalities. Upon final visit the patients will be examined using radiology, blood samples, biothesiometry and objective examinations, following up on the same examinations being made upon inclusion.
Primary outcome will be time until full remission of the Charcot foot defined as clinical healing (The acute Charcot foot is clinically healed when 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) followed up by radiological signs of healing.
10,923 studies on the registry are indexed under Diabetes Mellitus; 1,318 are open to participants now.
This study's planned enrollment of 38 is below the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus studies →Ole Lander Svendsen is the lead sponsor of 2 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
Drug: Denosumab Injection
Participants will receive an injection of placebo (saline) instead of Prolia
Drug: Denosumab Injection
Injections made subcutaneously per standard description
Time until remission
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. The off-loading regime will be continued until the second visit. The first of the two visits is the timepoint of healing of the acute Charcot foot.
Time frame: 52 weeks
Fraction of clinical healed participants at each study visit.
Time frame: 52 weeks
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.
Time frame: 52 weeks
Number of relapses (defined as need for/prescription of off- loading with cast of the Charcot foot again)
Time frame: 52 weeks
Time without relapse (the time from clinical healing/remission to the relapse or to End of Trial at 12 months).
Time frame: 52 weeks
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.
Time frame: 52 weeks
Changes in BMD (lumbar spine, hip)
Time frame: 52 weeks
Changes in markers of bone turnover (CTX and P1NP)
Time frame: 52 weeks
Changes in markers of glycemic control (HbA1c)
Time frame: 52 weeks
Incidence of Adverse Events and Serious Adverse Events
Time frame: 52 weeks
Plan to share: No
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Ole Lander Svendsen