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OpenTrials
Completed

NCT Number: NCT02386579

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

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.

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Key information

Conditions

Arthropathy, Neurogenic Diabetes Complications Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Joint Diseases Metabolic Diseases Musculoskeletal Diseases Nutritional and Metabolic Diseases

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Blood sample measurements

Procedure

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

Primary outcomes

  1. RANKL

    Time frame: 10 min between measurements

Secondary outcomes

  1. osteocalcin

    Time frame: 10 min between measurements

  2. CTX-I

    Time frame: 10 min between measurements

  3. sRAGE

    Time frame: 10 min between measurements

  4. P1NP

    Time frame: 10 min between measurements

Sponsors and collaborators

Lead sponsor

Bispebjerg Hospital

Other

Registry information

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Mar 12, 2015
Registry last updated
Mar 31, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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