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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02386579

Enrollment

Registered

2015-03-12

Start date

2015-02-28

Completion date

2017-06-30

Last updated

2020-03-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arthropathy, Neurogenic, Diabetes Complications, Diabetes Mellitus

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.

Interventions

PROCEDUREBlood sample measurements

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

Study design

Observational model

CASE_CONTROL

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
RANKL	10 min between measurements

Secondary

Measure	Time frame
osteocalcin	10 min between measurements
CTX-I	10 min between measurements
sRAGE	10 min between measurements
P1NP	10 min between measurements

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026