Characterization of Local and Systemic Bone Markers in Diabetes Patients With Charcot Osteoarthropathy

March 28, 2020 updated by: Rasmus Bo Jansen, Bispebjerg Hospital

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

5

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Diabetes patients with and without acute charcot foot

Description

Inclusion Criteria:

  • Diabetes mellitus type 1 or 2
  • Charcot foot diagnosed with x-ray, scintigraphy or clinical review by a specialist

Exclusion Criteria:

  • Osteoporosis
  • Anti-osteoporotic treatment
  • Lower extremity amputation
  • Lower extremity infection

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Diabetics with Charcot foot
Procedure: Blood sample measurements
Blood samples are drawn in the feet and arms (a/v) before and after cooling the feet with ice water

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
RANKL
Time Frame: 10 min between measurements
10 min between measurements

Secondary Outcome Measures

Outcome Measure
Time Frame
osteocalcin
Time Frame: 10 min between measurements
10 min between measurements
CTX-I
Time Frame: 10 min between measurements
10 min between measurements
sRAGE
Time Frame: 10 min between measurements
10 min between measurements
P1NP
Time Frame: 10 min between measurements
10 min between measurements

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bispebjerg Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2015

Primary Completion (Actual)

June 1, 2017

Study Completion (Actual)

June 1, 2017

Study Registration Dates

First Submitted

February 27, 2015

First Submitted That Met QC Criteria

March 6, 2015

First Posted (Estimate)

March 12, 2015

Study Record Updates

Last Update Posted (Actual)

March 31, 2020

Last Update Submitted That Met QC Criteria

March 28, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-1-2014-069

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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