Health TrialsbyHealthPanel

The DENOCHARCOT Trial

ConditionsCharcot FootDiabetes Mellitus
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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Denosumab Injection

    Drug

    Injections made subcutaneously per standard description

Treatment groups

38 Participants
are divided into 2 treatment groups
Group A: Denosumab treated groupExperimental treatment 1 intervention
Group B: Placebo treated groupPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

1

Fraction of clinical healed participants at each study visit.

Time frame
52 weeks
2

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
3

Number of relapses (defined as need for/prescription of off- loading with cast of the Charcot foot again)

Time frame
52 weeks
4

Time without relapse (the time from clinical healing/remission to the relapse or to End of Trial at 12 months).

Time frame
52 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ole Lander Svendsen

Lead sponsor

Bispebjerg Hospital

Sponsor institution

Source ClinicalTrials.gov
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