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NCT02386579 Clinical Trial

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

Diabetes Mellitus Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02386579
Other study ID # H-1-2014-069
Secondary ID
Status Completed
Phase
First received
Last updated
Start date February 2015
Est. completion date June 2017

Study information
Verified date March 2020
Source Bispebjerg Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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.

Patients will be compared with healthy diabetic controls.

Recruitment information / eligibility
Status Completed
Enrollment 5
Est. completion date June 2017
Est. primary completion date June 2017
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Bispebjerg Hospital

Outcome
Type Measure Description Time frame Safety issue
Primary RANKL 10 min between measurements
Secondary osteocalcin 10 min between measurements
Secondary CTX-I 10 min between measurements
Secondary sRAGE 10 min between measurements
Secondary P1NP 10 min between measurements
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