Arthropathy, NeurogenicNCT02386579
Characterization of Local and Systemic Bone Markers in Diabetes Patients With Charcot Osteoarthropathy
An observational study of Arthropathy, Neurogenic and Diabetes Complications, run by Bispebjerg Hospital.
Trial summary
The study is designed to investigate biomarkers related to bone turnover in diabetics with charcot foot. This is done by measuring local blood samples in the feet, and systemically in a vene and an artery. Measurements are done before and after cooling the feet in icewater to lower the bloodflow. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Arthropathy, Neurogenic, Diabetes Complications, Diabetes Mellitus
- What is being tested?
- Blood sample measurements
- Type of treatment
- Surgery or procedure
- How many people
- 5 participants
- Where
- No sites listed yet
- Study dates
- Feb 2015to Jun 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Diabetes patients with and without acute charcot foot
Who may be able to join
- Diabetes mellitus type 1 or 2
- Charcot foot diagnosed with x-ray, scintigraphy or clinical review by a specialist
Who cannot join
- Osteoporosis
- Anti-osteoporotic treatment
- Lower extremity amputation
- Lower extremity infection
About this study
The study is designed to investigate biomarkers related to bone turnover in diabetics with charcot foot. This is done by measuring local blood samples in the feet, and systemically in a vene and an artery. Measurements are done before and after cooling the feet in icewater to lower the bloodflow.
Patients will be compared with healthy diabetic controls.
- Being tested
- Blood sample measurements
- Medical subject headings
- Arthropathy, Neurogenic, Diabetes Complications, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood sample measurementsProcedure or surgery
Blood samples are drawn in the feet and arms (a/v) before and after cooling the feet with ice water
| Study group | Role | What they receive |
|---|---|---|
| Diabetics with Charcot foot | Not described Receives: Procedure: Blood sample measurements |
What is being measured
The primary outcome is the main question the study is designed to answer.
RANKL
Measured: 10 min between measurements
Secondary outcomes (4)
osteocalcin
Measured: 10 min between measurements
CTX-I
Measured: 10 min between measurements
sRAGE
Measured: 10 min between measurements
P1NP
Measured: 10 min between measurements
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2015 (estimated)
- Study startFeb 2015
- Primary completionJun 2017
- Study completionJun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arthropathy, NeurogenicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bispebjerg Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rasmus Bo Jansen, Bispebjerg Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02386579
- Sponsor's protocol ID
- H-1-2014-069
- Status last verified
- Mar 2020
- First submitted
- 27 Feb 2015
- Last updated
- 31 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization of Local and Systemic Bone Markers in Diabetes Patients With Charcot Osteoarthropathy
- ClinicalTrials.gov ID
- NCT02386579
- Acronym / sponsor ID
- H-1-2014-069
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Bispebjerg HospitalUniversity, hospital or other
- Study start
- Feb 2015
- Primary completion
- Jun 2017 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 12 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study is designed to investigate biomarkers related to bone turnover in diabetics with charcot foot. This is done by measuring local blood samples in the feet, and systemically in a vene and an artery. Measurements are done before and after cooling the feet in icewater to lower the bloodflow.
Patients will be compared with healthy diabetic controls.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diabetics with Charcot foot | – | Procedure: Blood sample measurements |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Diabetes patients with and without acute charcot foot
Key inclusion criteria (2 listed)
- Diabetes mellitus type 1 or 2
- Charcot foot diagnosed with x-ray, scintigraphy or clinical review by a specialist
Key exclusion criteria (4 listed)
- Osteoporosis
- Anti-osteoporotic treatment
- Lower extremity amputation
- Lower extremity infection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood sample measurementsBlood samples are drawn in the feet and arms (a/v) before and after cooling the feet with ice water | Procedure or surgery | Diabetics with Charcot foot |
Primary outcome
RANKL
Time frame: 10 min between measurements
4 secondary outcomes
osteocalcin
Time frame: 10 min between measurements
CTX-I
Time frame: 10 min between measurements
sRAGE
Time frame: 10 min between measurements
P1NP
Time frame: 10 min between measurements
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2020.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Arthropathy, Neurogenic and Diabetes Complications, run by Bispebjerg Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
RANKL (time frame: 10 min between measurements). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2020.