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

NCT ID: NCT02386579

Last Updated: 2020-03-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

5 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-02-28

Study Completion Date

2017-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Arthropathy, Neurogenic Diabetes Complications Diabetes Mellitus

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Diabetics with Charcot foot

Blood sample measurements

Intervention Type PROCEDURE

Blood samples are drawn in the feet and arms (a/v) before and after cooling the feet with ice water

Interventions

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Blood sample measurements

Blood samples are drawn in the feet and arms (a/v) before and after cooling the feet with ice water

Intervention Type PROCEDURE

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bispebjerg Hospital

OTHER

Sponsor Role lead

Responsible Party

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Rasmus Bo Jansen

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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H-1-2014-069

Identifier Type: -

Identifier Source: org_study_id

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