Characterization of Local and Systemic Bone Markers in Diabetes Patients With Charcot Osteoarthropathy
1 other identifier
observational
5
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Feb 2015
Typical duration for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2015
CompletedFirst Submitted
Initial submission to the registry
February 27, 2015
CompletedFirst Posted
Study publicly available on registry
March 12, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2017
CompletedMarch 31, 2020
March 1, 2020
2.3 years
February 27, 2015
March 28, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
RANKL
10 min between measurements
Secondary Outcomes (4)
osteocalcin
10 min between measurements
CTX-I
10 min between measurements
sRAGE
10 min between measurements
P1NP
10 min between measurements
Study Arms (1)
Diabetics with Charcot foot
Interventions
Blood samples are drawn in the feet and arms (a/v) before and after cooling the feet with ice water
Eligibility Criteria
Diabetes patients with and without acute charcot foot
You may qualify if:
- Diabetes mellitus type 1 or 2
- Charcot foot diagnosed with x-ray, scintigraphy or clinical review by a specialist
You may not qualify if:
- Osteoporosis
- Anti-osteoporotic treatment
- Lower extremity amputation
- Lower extremity infection
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Biospecimen
blood serum samples
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD
Study Record Dates
First Submitted
February 27, 2015
First Posted
March 12, 2015
Study Start
February 1, 2015
Primary Completion
June 1, 2017
Study Completion
June 1, 2017
Last Updated
March 31, 2020
Record last verified: 2020-03