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

Completed

• Conditions: Arthropathy, Neurogenic; Diabetes Complications; Diabetes Mellitus
• Interventions: Procedure: Blood sample measurements

• Registration Number: NCT02386579
• Lead Sponsor: Bispebjerg Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-02
• Study First Submitted: 2015-02-27
• Study First Submitted QC: 2015-03-06
• Study First Posted: 2015-03-12
• Primary Completion: 2017-06
• Study Completion: 2017-06
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-28
• Last Update Posted: 2020-03-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Diabetics with Charcot foot	Blood sample measurements	-

Primary Outcome Measures

Name	Time	Method
RANKL	10 min between measurements

Secondary Outcome Measures

Name	Time	Method
sRAGE	10 min between measurements
P1NP	10 min between measurements
osteocalcin	10 min between measurements
CTX-I	10 min between measurements