Characterization of Local and Systemic Bone Markers in Di... | NCT02386579

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

NCT02386579

Sponsor

Bispebjerg Hospital

Status

Completed

Last Update Posted

Mar 31, 2020Actual

Enrollment

5Actual

Phase

Not provided

Conditions

Arthropathy, Neurogenic
Diabetes Complications
Diabetes Mellitus

Interventions

Blood sample measurements

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2015

Primary Completion Date

Jun 2017Actual

Completion Date

Jun 2017Actual

First Submitted Date

Feb 27, 2015

First Submission Date that Met QC Criteria

Mar 6, 2015

First Posted Date

Mar 12, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 28, 2020

Last Update Posted Date

Mar 31, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

5Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Diabetics with Charcot foot			Procedure: Blood sample measurements

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Blood sample measurements	Procedure	Blood samples are drawn in the feet and arms (a/v) before and after cooling the feet with ice water	Diabetics with Charcot foot

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
RANKL		10 min between measurements

Secondary Outcomes

Measure	Description	Time Frame
osteocalcin		10 min between measurements
CTX-I		10 min between measurements
sRAGE

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Diabetes patients with and without acute charcot foot

Sampling Method

Non-Probability Sample

Condition Browse Module

MeSH Terms

ID	Term
D001177	Arthropathy, Neurogenic
D048909	Diabetes Complications
D003920	Diabetes Mellitus

Ancestor Terms

ID	Term
D007592	Joint Diseases
D009140	Musculoskeletal Diseases
D004700	Endocrine System Diseases
D044882	Glucose Metabolism Disorders

Browse Leaves

Not provided

Browse Branches

Not provided